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EXHIBIT “A”
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Title 26
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Guam Administrative Rules and Regulations
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Division 1, Chapter 4,
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Article 4A
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GUAM
FOOD CODE
REGULATIONS GOVERNING SAFE FOOD HANDLING AND THE SANITARY
OPERATION OF RETAIL FOOD ESTABLISHMENTS
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________________________________________________________________________
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10
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REGULATIONS GOVERNING SAFE
FOOD HANDLING AND THE SANITARY
OPERATION OF FOOD
ESTABLISHMENTS TO PREVENT
FOODBORNE ILLNESS
_______________________________________________________________________
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DEPARTMENT OF PUBLIC HEALTH AND SOCIAL SERVICES
DIVISION OF ENVIRONMENTAL HEALTH
123 CHALAN KARETA
MANGILAO, GUAM 96913-6403
04.05.11
1
Chapter
2
1
3
Parts
4
1-1
TITLE, INTENT, SCOPE
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1-2
DEFINITIONS
1-1
TITLE, INTENT, SCOPE
Purpose and Definitions
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7
8
Subparts
9
1-101
Title
10
1-102
Intent
11
1-103
Scope
1-101.10
Guam Food Code.
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13
Title
14
These provisions shall be known as the Guam Food Code, hereinafter
15
referred to as “this Code.”
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Intent
1-102.10
Food Safety, Illness Prevention, and Honest Presentation.
17
The purpose of this Code is to safeguard public health and provide to
18
CONSUMERS FOOD
19
Scope
1-103.10
that is safe, unADULTERATED, and honestly presented.
Statement.
20
This Code establishes definitions; sets standards for management and
21
personnel, FOOD operations, and EQUIPMENT and facilities; and provides for
22
FOOD ESTABLISHMENT
23
RESTRICTION,
plan review,
PERMIT
issuance, inspection,
and PERMIT suspension.
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25
1-2 DEFINITIONS
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Subpart
27
1-201
Applicability and Terms Defined
1
EMPLOYEE
1
Applicability
2
and Terms
3
Defined
4
(A)
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6
9
(B)
The following definitions shall apply in the interpretation and application of
Terms Defined.
Accredited Program.
(1)
“Accredited program” means a food protection manager certification
program that has been evaluated and listed by a REGULATORY AUTHORITY.
(2)
12
“Accredited program” does not refer to training functions or educational
programs.
13
Additive.
14
(1)
“Food additive” has the meaning stated in the Federal Food, Drug, and
Cosmetic Act, § 201(s) and 21 CFR 170.3(e)(1).
15
16
As used in this Code, each of the terms listed in
¶ 1-201.10(B) shall have the meaning stated below.
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04.05.11
Statement of Application and Listing of Terms.
this Code.
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8
1-201.10
(2)
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“Color additive” has the meaning stated in the Federal Food, Drug, and
Cosmetic Act, § 201(t) and 21 CFR 70.3(f).
18
“Adulterated” has the meaning stated in the Federal Food, Drug, and Cosmetic
19
Act, § 402.
20
“Approved” means acceptable to the
21
determination of conformity with principles, practices, and generally recognized
22
standards that protect public health.
23
Asymptomatic.
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(1)
REGULATORY AUTHORITY
based on a
“Asymptomatic” means without obvious symptoms; not showing or
25
producing indications of a disease or other medical condition, such as an
26
individual infected with a pathogen but not exhibiting or producing any signs
27
or symptoms of vomiting, diarrhea, or jaundice.
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29
(2)
“Asymptomatic” includes not showing symptoms because symptoms have
resolved or subsided, or because symptoms never manifested.
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“aw” means water activity which is a measure of the free moisture in a FOOD, is the
2
quotient of the water vapor pressure of the substance divided by the vapor pressure
3
of pure water at the same temperature, and is indicated by the symbol
4
“Balut” means an embryo inside a fertile EGG that has been incubated for a period
5
sufficient for the embryo to reach a specific stage of development after which it is
6
removed from incubation before hatching.
7
“Beverage” means a liquid for drinking, including water.
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“Bottled drinking water” means water that is SEALED in bottles, packages, or other
9
containers and offered for sale for human consumption, including bottled mineral
AW .
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water.
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“Casing” means a tubular container for sausage products made of either
12
natural or artificial (synthetic) material.
13
“Certification number” means a unique combination of letters and numbers
14
assigned by a
15
according to the provisions of the National Shellfish Sanitation Program.
16
“CFR” means CODE OF FEDERAL REGULATIONS. Citations in this Code to the CFR
17
refer sequentially to the Title, Part, and Section numbers, such as 40 CFR 180.194
18
refers to Title 40, Part 180, Section 194.
19
CIP.
20
(1)
SHELLFISH CONTROL AUTHORITY
to a
MOLLUSCAN SHELLFISH DEALER
“CIP” means cleaned in place by the circulation or flowing by mechanical
21
means through a piping system of a detergent solution, water rinse, and
22
SANITIZING
23
such as the method used, in part, to clean and
24
machine.
25
(2)
solution onto or over
EQUIPMENT
“CIP” does not include the cleaning of
surfaces that require cleaning,
SANITIZE
EQUIPMENT
a frozen dessert
such as band saws,
26
slicers, or mixers that are subjected to in-place manual cleaning without the
27
use of a CIP system.
28
“Commingle” means:
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(1)
30
growing areas as identified on the tag or label, or
To combine SHELLSTOCK harvested on different days or from different
3
1
(2)
2
To combine
codes or different shucking dates.
3
Comminuted.
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(1)
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from containers with different container
SHUCKED SHELLFISH
“Comminuted” means reduced in size by methods including chopping,
flaking, grinding, or mincing.
(2)
“Comminuted” includes FISH or MEAT products that are reduced in size and
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restructured or reformulated such as gefilte
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sausage; and a mixture of 2 or more types of MEAT that have been reduced in
9
size and combined, such as sausages made from 2 or more MEATS.
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“Conditional employee” means a potential FOOD EMPLOYEE to whom a job offer is
11
made, conditional on responses to subsequent medical questions or examinations
12
designed to identify potential FOOD EMPLOYEES who may be suffering from a disease
13
that can be transmitted through
14
Americans with Disabilities Act of 1990.
15
“Confirmed disease outbreak” means a
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laboratory analysis of appropriate specimens identifies a causative agent or
17
epidemiological analysis implicates a FOOD as the source of the illness.
18
“Consumer” means a PERSON who is a member of the public, takes possession of
19
FOOD,
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FOOD ESTABLISHMENT or FOOD PROCESSING PLANT,
21
FOOD
FISH,
gyros, ground beef, and
and done in compliance with Title 1 of the
FOODBORNE DISEASE OUTBREAK
in which
is not functioning in the capacity of an operator of a
FOOD for
and does not offer the
resale.
22
“Corrosion-resistant material” means a material that maintains acceptable
23
surface cleanability characteristics under prolonged influence of the
24
contacted, the normal use of cleaning compounds and
25
other conditions of the use environment.
26
“Counter-mounted equipment” means
27
designed to be mounted off the floor on a table, counter, or shelf.
28
“Critical control point” means a point or procedure in a specific
29
where loss of control may result in an unacceptable health RISK.
4
EQUIPMENT
SANITIZING
FOOD
to be
solutions, and
that is not portable and is
FOOD
system
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1
Critical Item.
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(1)
“Critical item” means a provision of this Code, that, if in noncompliance, is
3
more likely than other violations to contribute to FOOD contamination, illness,
4
or environmental health HAZARD.
“Critical item” is an item that is denoted in this Code with an asterisk *.
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(2)
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“Critical limit” means the maximum or minimum value to which a physical,
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biological, or chemical parameter must be controlled at a CRITICAL CONTROL POINT to
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minimize the RISK that the identified FOOD safety HAZARD may occur.
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“Dealer” means a PERSON who is authorized by a SHELLFISH CONTROL AUTHORITY for
10
the activities of
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depuration processor of
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National Shellfish Sanitation Program.
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“Disclosure” means a written statement that clearly identifies the animal-derived
14
FOODS
15
processed to eliminate pathogens, or items that contain an ingredient that is raw,
16
undercooked, or without otherwise being processed to eliminate pathogens.
17
Drinking Water.
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(1)
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SHELLSTOCK
shipper, shucker-packer, repacker, reshipper, or
MOLLUSCAN SHELLFISH
according to the provisions of the
which are, or can be ordered, raw, undercooked, or without otherwise being
“Drinking water” means water that meets criteria as specified in 40CFR
141 National Primary Drinking Water Regulations.
20
(2)
“Drinking water” is traditionally known as “potable water.”
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(3)
“Drinking water” includes the term “water” except where the term used
22
connotes that the water is not potable, such as “boiler water,” “mop water,”
23
“rainwater,” “wastewater,” and “nondrinking” water.
24
“Dry storage area” means a room or area designated for the storage of PACKAGED
25
or containerized bulk
26
CONTROL FOR SAFETY FOOD)
FOOD
that is not
POTENTIALLY HAZARDOUS (TIME/TEMPERATURE
and dry goods such as SINGLE-SERVICE items.
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Easily Cleanable.
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(1)
“Easily cleanable” means a characteristic of a surface that:
3
(a)
Allows effective removal of soil by normal cleaning methods;
4
(b)
Is dependent on the material, design, construction, and installation of
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the surface; and
6
(c)
Varies with the likelihood of the surface's role in introducing
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pathogenic or toxigenic agents or other contaminants into FOOD based
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on the surface's APPROVED placement, purpose, and use.
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(2)
“Easily cleanable” includes a tiered application of the criteria that qualify
10
the surface as
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definition to different situations in which varying degrees of cleanability are
12
required such as:
13
(a)
EASILY CLEANABLE
as specified in Subparagraph (1) of this
The appropriateness of stainless steel for a FOOD preparation surface
14
as opposed to the lack of need for stainless steel to be used for floors
15
or for tables used for CONSUMER dining; or
16
(b)
The need for a different degree of cleanability for a utilitarian
17
attachment or accessory in the kitchen as opposed to a decorative
18
attachment or accessory in the CONSUMER dining area.
19
“Easily movable” means:
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(1)
21
22
Portable; mounted on casters, gliders, or rollers; or provided with a
mechanical means to safely tilt a unit of EQUIPMENT for cleaning; and
(2)
Having no utility connection, a utility connection that disconnects quickly, or
23
a flexible utility connection line of sufficient length to allow the EQUIPMENT to
24
be moved for cleaning of the EQUIPMENT and adjacent area.
25
Egg.
26
(1)
27
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“Egg” means the shell
EGG of
avian species such as chicken, duck,
goose, guinea, quail, RATITES or turkey.
(2)
“Egg” does not include:
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(a)
A BALUT;
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(b)
The egg of reptile species such as alligator; or
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1
(c)
An EGG PRODUCT.
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Egg Product.
3
(1)
“Egg Product” means all, or a portion of, the contents found inside
EGGS
4
separated from the shell and pasteurized in a FOOD PROCESSING PLANT, with
5
or without added ingredients, intended for human consumption, such as
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dried, frozen or liquid eggs.
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(2)
8
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“Egg Product” does not include FOOD which contains EGGS only in a
relatively small proportion such as cake mixes.
“Employee” means the PERMIT HOLDER, PERSON IN CHARGE, FOOD EMPLOYEE,
10
PERSON
having supervisory or management duties,
11
member, volunteer, PERSON performing work under contractual agreement, or other
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PERSON
13
“Enterohemorrhagic Escherichia coli” (EHEC) means E. coli which cause
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hemorrhagic colitis, meaning bleeding enterically or bleeding from the intestine.
15
The term is typically used in association with E. coli that have the capacity to
16
produce Shiga toxins and to cause attaching and effacing lesions in the intestine.
17
EHEC is a subset of STEC, whose members produce additional virulence factors.
18
Infections with EHEC may be asymptomatic but are classically associated with
19
bloody diarrhea (hemorrhagic colitis) and hemolytic uremic syndrome (HUS) or
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thrombotic thrombocytopenic purpura (TTP). Examples of serotypes of EHEC
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include: E. coliO157:H7; E. coli O157:NM; E. coli O26:H11; E. coli O145:NM; E.
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coli O103:H2; or E. coli O111:NM. Also see SHIGA TOXIN-PRODUCING E. COLI.
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“EPA” means the U.S. Environmental Protection Agency.
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Equipment.
25
(1)
PERSON
on the payroll, family
working in a FOOD ESTABLISHMENT.
“Equipment” means an article that is used in the operation of a
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ESTABLISHMENT
27
mixer, oven, reach-in refrigerator, scale, sink, slicer, stove, table,
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TEMPERATURE MEASURING DEVICE
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WAREWASHING machine.
30
(2)
such as a freezer, grinder, hood, ice maker,
FOOD
for ambient air,
MEAT
block,
VENDING MACHINE,
or
“Equipment” does not include apparatuses used for handling or storing
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that are received from a supplier in a
1
large quantities of
2
cased or overwrapped lot, such as hand trucks, forklifts, dollies, pallets,
3
racks, and skids.
4
“Exclude” means to prevent a
5
ESTABLISHMENT
6
“FDA” means the U.S. Food and Drug Administration.
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Fish.
8
(1)
PACKAGED FOODS
PERSON
from working as an
EMPLOYEE
in a
FOOD
or entering a FOOD ESTABLISHMENT as an EMPLOYEE.
“Fish” means fresh or saltwater finfish, crustaceans and other forms of
9
aquatic life (including alligator, frog, aquatic turtle, jellyfish, sea cucumber,
10
and sea urchin and the roe of such animals) other than birds or mammals,
11
and all mollusks, if such animal life is intended for human consumption.
12
(2)
13
“Fish” includes an edible human FOOD product derived in whole or in
part from FISH, including FISH that have been processed in any manner.
14
“Food” means a raw, cooked, or processed edible substance, ice,
15
ingredient used or intended for use or for sale in whole or in part for human
16
consumption, or chewing gum.
17
“Foodborne disease outbreak” means the occurrence of two or more cases of a
18
similar illness resulting from the ingestion of a common FOOD.
19
“Food-contact surface” means:
20
(1)
21
22
A surface of
EQUIPMENT
or a
UTENSIL
with which
FOOD
BEVERAGE,
or
normally comes into
contact; or
(2)
A surface of EQUIPMENT or a UTENSIL from which FOOD may drain, drip,
23
or splash:
24
(a)
Into a FOOD, or
25
(b)
Onto a surface normally in contact with FOOD.
26
“Food employee” means an individual working at
27
PACKAGED, UNPACKAGED FOOD, FOOD EQUIPMENT
28
SURFACES.
29
Food Establishment.
30
(1)
or
FOOD ESTABLISHMENTS
UTENSILS,
or
with
FOOD-CONTACT
“Food establishment” means an operation that stores, prepares,
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packages, serves, vends food directly to the consumer, or otherwise
2
provides FOOD for human consumption:
3
(a)
Such as a restaurant; satellite or catered feeding location; catering
4
operation if the operation provides FOOD directly to a CONSUMER or to a
5
conveyance used to transport people; market; vending location;
6
conveyance used to transport people; institution; or FOOD bank; and
7
(b)
That relinquishes possession of
FOOD
to a
CONSUMER
directly, or
8
indirectly through a delivery service such as home delivery of grocery
9
orders or restaurant takeout orders, or delivery service that is
10
11
provided by common carriers.
(2)
12
“Food establishment” includes:
(a)
An element of the operation such as a transportation vehicle or a
13
central preparation facility that supplies a vending location or satellite
14
feeding location unless the vending or feeding location is permitted by
15
the REGULATORY AUTHORITY; and
16
(b)
An operation that is conducted in a mobile, stationary, temporary, or
17
permanent facility or location; where consumption is on or off the
18
PREMISES;
19
(3)
and regardless of whether there is a charge for the FOOD.
“Food establishment” does not include:
20
(a) A produce stand that only offers whole, uncut fresh fruits and vegetables;
21
(b)
22
23
A
FOOD PROCESSING PLANT;
PREMISES
(c)
including those that are located on the
of a FOOD ESTABLISHMENT;
A kitchen in a private home if only
FOOD
that is not
POTENTIALLY
24
HAZARDOUS (TIME/TEMPERATURE CONTROL FOR SAFETY) FOOD, is prepared
25
for sale or service at a function such as a religious or charitable
26
organization's bake sale if allowed by
27
informed by a clearly visible placard at the sales or service location
28
that the FOOD is prepared in a kitchen that is not subject to regulation
29
and inspection by the REGULATORY AUTHORITY;
30
(d)
An area where
FOOD
LAW
and if the
CONSUMER
is
that is prepared as specified in Subparagraph
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04.05.11
(3)(c) of this definition is sold or offered for human consumption;
1
2
(e)
A kitchen in a private home, such as a small family day-care provider;
3
or a bed-and-breakfast operation that prepares and offers
4
guests if the home is owner occupied, the number of available guest
5
bedrooms does not exceed 6, breakfast is the only meal offered, the
6
number of guests served does not exceed 18, and THE CONSUMER is
7
informed by statements contained in published advertisements,
8
mailed brochures, and placards posted at the registration area that
9
the FOOD is prepared in a kitchen that is not regulated and inspected
10
FOOD
to
by the REGULATORY AUTHORITY; or
11
(f)
A private home that receives catered or home-delivered FOOD.
12
“Food processing plant” means a commercial operation that manufactures,
13
packages, labels, or stores
14
sale or distribution to other business entities such as FOOD PROCESSING PLANTS or
15
FOOD ESTABLISHMENTS.
16
Game Animal.
17
(1)
FOOD
for human consumption, and provides
“Game animal” means an animal, the products of which are
FOOD
FOOD,
for
that is
18
not classified as livestock, sheep, swine, goat, horse, mule, or other equine
19
in 9 CFR 301.2 Definitions, or as Poultry, or FISH.
20
(2)
“Game animal” includes mammals such as reindeer, elk, deer, antelope,
21
water buffalo, bison, rabbit, squirrel, opossum, raccoon, nutria, or muskrat,
22
and nonaquatic reptiles such as land snakes.
“Game animal” does not include RATITES.
23
(3)
24
“General use pesticide” means a pesticide that is not classified by EPA for
25
restricted use as specified in 40 CFR 152.175. Pesticides classified for restricted
26
use.
27
“Grade A standards” means the requirements of the United States Public Health
28
Service/FDA “ Grade A Pasteurized Milk Ordinance” with which certain fluid and dry
29
milk and milk products comply.
30
“HACCP plan” means a written document that delineates the formal procedures for
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04.05.11
following the HAZARD Analysis and CRITICAL CONTROL POINT principles developed by
2
The National Advisory Committee on Microbiological Criteria for Foods.
3
Handwashing Sink.
4
(1)
“Handwashing sink” means a lavatory, a basin or vessel for washing, a
5
wash basin, or a
6
hygiene and designed for the washing of the hands.
PLUMBING FIXTURE
especially placed for use in personal
“Handwashing sink” includes an automatic handwashing facility.
7
(2)
8
“Hazard” means a biological, chemical, or physical property that may cause an
9
unacceptable CONSUMER health RISK.
10
“Health practitioner” means a physician licensed to practice medicine, or if
11
allowed by
12
professional.
13
“Hermetically sealed container” means a container that is designed and intended
14
to be secure against the entry of microorganisms and, in the case of low acid
15
canned FOODS, to maintain the commercial sterility of its contents after processing.
16
“Highly susceptible population” means PERSONS who are more likely than other
17
people in the general population to experience foodborne disease because they
18
are:
19
(1)
Immunocompromised; preschool age children, or older adults; and
20
(2)
Obtaining
LAW ,
a nurse practitioner, physician assistant, or similar medical
FOOD
at a facility that provides services such as custodial care,
21
health care, or assisted living, such as a child or adult day care center,
22
kidney dialysis center, hospital or nursing home, or nutritional or
23
socialization services such as a senior center.
24
“Imminent health hazard” means a significant threat or danger to health that is
25
considered to exist when there is evidence sufficient to show that a product,
26
practice, circumstance, or event creates a situation that requires immediate
27
correction or cessation of operation to prevent injury based on:
28
(1)
The number of potential injuries, and
29
(2)
The nature, severity, and duration of the anticipated injury.
30
“Injected” means manipulating a MEAT so that infectious or toxigenic
11
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04.05.11
microorganisms may be introduced from its surface to its interior through
2
tenderizing with deep penetration or injecting the MEAT such as by processes which
3
may be referred to as “injecting,” “pinning,” or “stitch pumping.”
4
Juice.
5
(1)
“Juice” means the aqueous liquid expressed or extracted from one
6
or more fruits or vegetables, purées of the edible portions of one or
7
more fruits or vegetables, or any concentrates of such liquid or purée.
8
(2)
9
“Juice” does not include, for purposes of HACCP, liquids, purées, or
concentrates that are not used as
10
BEVERAGES
or ingredients of
BEVERAGES.
11
“Kitchenware” means FOOD preparation and storage UTENSILS.
12
“Law” means applicable local, state, and federal statutes, regulations, and
13
ordinances.
14
“Linens” means fabric items such as cloth hampers, cloth napkins, table cloths,
15
wiping cloths, and work garments including cloth gloves.
16
Major Food Allergen.
17
(1)
18
“Major food allergen” means:
(a)
Milk, EGG, fish (such as bass, flounder, cod, and including crustacean
19
shellfish such as crab, lobster, or shrimp), tree nuts (such as
20
almonds, pecans, or walnuts), wheat, peanuts, and soybeans; or
21
(b)
22
23
24
A
FOOD
ingredient that contains protein derived from a
FOOD,
as
specified in Subparagraph (1)(a) of this definition.
(2)
“Major food allergen” does not include:
(a)
Any highly refined oil derived from a FOOD specified in Subparagraph
25
(1)(a) of this definition and any ingredient derived from such highly
26
refined oil; or
27
(b)
Any ingredient that is exempt under the petition or notification process
28
specified in the Food Allergen Labeling and Consumer Protection Act
29
of 2004 (Public Law 108-282).
30
“Meat” means the flesh of animals used as
12
FOOD
including the dressed flesh of
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04.05.11
cattle, swine, sheep, or goats and other edible animals, except FISH, POULTRY, and
2
wild GAME ANIMALS as specified under Subparagraphs 3-201.17(A)(3) and (4).
3
“mg/L” means milligrams per liter, which is the metric equivalent of parts per million
4
(ppm).
5
“Molluscan shellfish” means any edible species of fresh or frozen oysters, clams,
6
mussels, and scallops or edible portions thereof, except when the scallop product
7
consists only of the shucked adductor muscle.
8
Packaged.
9
(1)
“Packaged” means bottled, canned, cartoned, securely bagged, or securely
10
wrapped, whether PACKAGED in a FOOD ESTABLISHMENT or a FOOD PROCESSING
11
PLANT.
12
(2)
“Packaged” does not include a wrapper, carry-out box, or other nondurable
13
container used to containerize
14
protection during service and receipt of the FOOD by the CONSUMER.
15
“Permit” means the document issued by the REGULATORY AUTHORITY that authorizes
16
a PERSON to operate a FOOD ESTABLISHMENT.
17
“Permit holder” means the entity that:
18
(1)
19
FOOD
with the purpose of facilitating
FOOD
Is legally responsible for the operation of the FOOD ESTABLISHMENT such as
the owner, the owner's agent, or other PERSON; and
20
(2)
Possesses a valid PERMIT to operate a FOOD ESTABLISHMENT.
21
“Person” means an association, a corporation, individual, partnership, other legal
22
entity, government, or governmental subdivision or agency.
23
“Person in charge” means the individual present at a FOOD ESTABLISHMENT who is
24
responsible for the operation at the time of inspection.
25
Personal Care Items.
26
(1)
“Personal care items” means items or substances that may be poisonous,
27
toxic, or a source of contamination and are used to maintain or enhance a
28
PERSON'S
health, hygiene, or appearance.
13
1
(2)
04.05.11
“Personal care items” include items such as medicines; first aid supplies;
2
and other items such as cosmetics, and toiletries such as toothpaste and
3
mouthwash.
4
“pH” means the symbol for the negative logarithm of the hydrogen ion
5
concentration, which is a measure of the degree of acidity or alkalinity of a
6
solution.
7
Values between 0 and 7 indicate acidity and values between 7 and 14 indicate
8
alkalinity. The value for pure distilled water is 7, which is considered neutral.
9
“Physical facilities” means the structure and interior surfaces of a
FOOD
10
ESTABLISHMENT
11
attachments such as light fixtures and heating or air conditioning system vents.
12
“Plumbing fixture” means a receptacle or device that:
13
(1)
14
15
including accessories such as soap and towel dispensers and
Is permanently or temporarily connected to the water distribution system of
the PREMISES and demands a supply of water from the system; or
(2)
16
Discharges used water, waste materials, or SEWAGE directly or indirectly to
the drainage system of the PREMISES.
17
“Plumbing system” means the water supply and distribution pipes;
18
FIXTURES
19
building drains, including their respective connections, devices, and appurtenances
20
within the PREMISES; and water-treating EQUIPMENT.
21
“Poisonous or toxic materials” means substances that are not intended for
22
ingestion and are included in 4 categories:
23
(1)
PLUMBING
and traps; soil, waste, and vent pipes; sanitary and storm sewers and
Cleaners and SANITIZERS, which include cleaning and SANITIZING agents and
24
agents such as caustics, acids, drying agents, polishes, and other
25
chemicals;
26
(2)
27
28
Pesticides, except SANITIZERS, which include substances such as insecticides
and rodenticides;
(3)
Substances necessary for the operation and maintenance of the
29
establishment such as nonfood grade lubricants and
30
that may be deleterious to health; and
14
PERSONAL CARE ITEMS
1
04.05.11
Substances that are not necessary for the operation and maintenance of the
(4)
2
establishment and are on the
3
products and paints.
PREMISES
for retail sale, such as petroleum
4
Potentially Hazardous Food (Time/Temperature Control for Safety Food).
5
(1)
“Potentially hazardous food (time/temperature control for safety food)”
6
means a FOOD that requires time/temperature control for safety (TCS) to limit
7
pathogenic microorganism growth or toxin formation.
8
“Potentially hazardous food (time/temperature control for safety food)”
(2)
9
includes:
10
(a)
An animal FOOD that is raw or heat-treated; a plant FOOD that is heat-
11
treated or consists of raw seed sprouts, cut melons, cut tomatoes or
12
mixtures of cut tomatoes that are not modified in a way so that they
13
are unable to support pathogenic microorganism growth or toxin
14
formation, or garlic-in-oil mixtures that are not modified in a way that
15
results in mixtures that do not support pathogenic microorganism
16
growth or toxin formation; and
17
(b)
Except as specified in Subparagraph (3)(d) of this definition, a FOOD
18
that because of the interaction of its AW and PH values is designated
19
as Product Assessment Required (PA) in Table A or B of this
20
definition:
21
Table A.
Interaction of PH and
22
destroy vegetative cells and subsequently PACKAGED
AW
for control of spores in
FOOD
heat-treated to
23
24
AW values
25
26
<0.92
27
28
> 0.92 - .95
29
30
> 0.95
PH
values
4.6 or less
> 4.6 - 5.6
> 5.6
non-PHF*/non-
non-PHF/non-
non-PHF/non-
TCS FOOD**
TCS FOOD
TCS FOOD
non-PHF/non-
non-PHF/non-
PA***
TCS FOOD
TCS FOOD
non-PHF/non-
PA
15
PA
04.05.11
1
TCS FOOD
2
*
3
** TCS FOOD means TIME/TEMPERATURE CONTROL FOR SAFETY FOOD
4
*** PA means Product Assessment required
PHF means POTENTIALLY HAZARDOUS FOOD
5
6
Table B. Interaction of PH and AW for control of vegetative cells and spores in FOOD
7
not heat-treated or heat-treated but not PACKAGED
8
9
AW values
PH
10
11
< 4.2
< 0.88
12
13
0.88 – 0.90
14
15
> 0.90 – 0.92
16
17
> 0.92
4.2 - 4.6
> 4.6 - 5.0
> 5.0
non-PHF*/non-
non-PHF/non-
non-PHF/non-
non-PHF/non-
TCS food**
TCS food
TCS food
TCS food
non-PHF/non-
non-PHF/non-
non-PHF/non-
TCS food
TCS food
TCS food
non-PHF/non-
non-PHF/non-
TCS food
TCS food
on-PHF/non-
18
values
PA
PA***
PA
PA
PA
PA
TCS food
19
*
20
** TCS FOOD means TIME/TEMPERATURE CONTROL FOR SAFETY FOOD
21
*** PA means Product Assessment required
22
(3)
PHF means POTENTIALLY HAZARDOUS FOOD
“Potentially hazardous food (time/temperature control for safety food)”
23
does not include:
24
(a)
An air-cooled hard-boiled
EGG
with shell intact, or an
EGG
with shell
25
intact that is not hard-boiled, but has been pasteurized to destroy all
26
viable salmonellae;
27
(b)
A
FOOD
in an unopened
HERMETICALLY SEALED CONTAINER
that is
28
commercially processed to achieve and maintain commercial sterility
29
under conditions of non-refrigerated storage and distribution;
16
1
(c)
04.05.11
A FOOD that because of its PH or AW value, or interaction of AW and PH
2
values, is designated as a non-PHF/non-TCS FOOD in Table A or B of
3
this definition;
4
(d)
A
FOOD
that is designated as Product Assessment Required (PA) in
5
Table A or B of this definition and has undergone a Product
6
Assessment showing that the growth or toxin formation of pathogenic
7
microorganisms that are reasonably likely to occur in that
8
precluded due to:
9
(i)
Intrinsic factors including added or natural characteristics of the
10
FOOD
11
acidulants, or nutrients,
12
FOOD Is
(ii)
such as preservatives, antimicrobials, humectants,
Extrinsic factors including environmental or operational factors
13
that affect the FOOD such as packaging, modified atmosphere
14
such as
15
temperature range of storage and use, or
16
(iii)
17
(e)
A
REDUCED OXYGEN PACKAGING,
shelf life and use, or
A combination of intrinsic and extrinsic factors; or
FOOD
that does not support the growth or toxin formation of
18
pathogenic microorganisms in accordance with one of the
19
Subparagraphs (3)(a) - (3)(d) of this definition even though the FOOD
20
may contain a pathogenic microorganism or chemical or physical
21
contaminant at a level sufficient to cause illness or injury.
22
“Poultry” means:
23
(1)
Any domesticated bird (chickens, turkeys, ducks, geese, guineas, RATITES, or
24
squabs), whether live or dead, as defined in 9 CFR 381.1 Poultry Products
25
Inspection Regulations Definitions, Poultry; and
26
(2)
Any migratory waterfowl or game bird, pheasant, partridge, quail, grouse, or
27
pigeon, whether live or dead, as defined in 9 CFR 362.1 Voluntary Poultry
28
Inspection Regulations, Definitions.
29
“Premises” means:
30
(1)
The
PHYSICAL FACILITY,
its contents, and the contiguous land or property
17
04.05.11
1
2
under the control of the PERMIT HOLDER; or
(2)
The PHYSICAL FACILITY, its contents, and the land or property not described in
3
Subparagraph (1) of this definition if its facilities and contents are under the
4
control of the PERMIT HOLDER and may impact FOOD ESTABLISHMENT personnel,
5
facilities, or operations, and a FOOD ESTABLISHMENT is only one component of
6
a larger operation such as a health care facility, hotel, motel, school,
7
recreational camp, or prison.
8
“Primal cut” means a basic major cut into which carcasses and sides of MEAT are
9
separated, such as a beef round, pork loin, lamb flank, or veal breast.
10
“Public water system” has the meaning stated in 40 CFR 141 National Primary
11
Drinking Water Regulations.
12
“Ratite” means a flightless bird such as an emu, ostrich, or rhea.
13
Ready-to-Eat Food.
14
(1)
15
“Ready-to-eat food” means FOOD that:
(a)
Is in a form that is edible without additional preparation to achieve
16
FOOD safety, as specified under one of the following: ¶ 3-401.11(A) or
17
(B), § 3-401.12, or § 3-402.11, or as specified in ¶ 3-401.11(C); or
18
(b)
19
as specified in Subparagraphs 3-401.11(D)(1) and (2); or
20
(c)
21
(d)
23
25
(2)
“Ready-to-eat food” includes:
(a)
30
Raw animal
FOOD
that is cooked as specified under § 3-401.11 or
3-401.12, or frozen as specified under § 3-402.11;
(b)
28
29
May receive additional preparation for palatability or aesthetic,
epicurean, gastronomic, or culinary purposes.
26
27
Is prepared in accordance with a variance that is granted as specified
in Subparagraphs 3-401.11(D) and (3); and
22
24
Is a raw or partially cooked animal FOOD and the consumer is advised
Raw fruits and vegetables that are washed as specified under §
3-302.15;
(c)
Fruits and vegetables that are cooked for hot holding, as specified
under § 3-401.13;
18
04.05.11
1
(d)
All
POTENTIALLY HAZARDOUS FOOD
(TIME/TEMPERATURE
CONTROL FOR
2
SAFETY FOOD)
3
the specific FOOD under Subpart 3-401 and cooled as specified under
4
§ 3-501.14;
5
(e)
that is cooked to the temperature and time required for
Plant FOOD for which further washing, cooking, or other processing is
6
not required for
7
shells, if naturally present are removed;
8
(f)
9
FOOD
safety, and from which rinds, peels, husks, or
Substances derived from plants such as spices, seasonings, and
sugar;
10
(g)
11
A bakery item such as bread, cakes, pies, fillings, or icing for which
further cooking is not required for
12
(h)
FOOD
safety;
The following products that are produced in accordance with USDA
13
guidelines and that have received a lethality treatment for pathogens:
14
dry, fermented sausages, such as dry salami or pepperoni; salt-cured
15
MEAT
16
ham, and Parma ham; and dried MEAT and POULTRY products, such as
17
jerky or beef sticks; and
18
(i)
and
POULTRY
products, such as prosciutto ham, country cured
FOODS manufactured as specified in 21 CFR Part 113, Thermally
19
Processed Low-Acid Foods Packaged in Hermetically Sealed
20
Containers.
21
Reduced Oxygen Packaging.
22
(1)
23
“Reduced oxygen packaging” means:
(a)
The reduction of the amount of oxygen in a
PACKAGE
by removing
24
oxygen; displacing oxygen and replacing it with another gas or
25
combination of gases; or otherwise controlling the oxygen content to a
26
level below that normally found in the atmosphere (approximately
27
21% at sea level); and
19
1
(b)
04.05.11
A process as specified in Subparagraph (1)(a) of this definition that
2
involves a
3
Listeria monocytogenes require control in the final PACKAGED form.
4
5
(2)
FOOD
for which the
Clostridium botulinum or
“Reduced oxygen packaging” includes:
(a)
Vacuum PACKAGING, in which air is removed from a PACKAGE of FOOD
6
and the
7
inside the PACKAGE;
8
HAZARDS
(b)
9
PACKAGE
is
HERMETICALLY SEALED
Modified atmosphere
PACKAGE
of
FOOD
PACKAGING,
so that a vacuum remains
in which the atmosphere of a
is modified so that its composition is different from
10
air but the atmosphere may change over time due to the permeability
11
of the
12
atmosphere PACKAGING includes reduction in the proportion of oxygen,
13
total replacement of oxygen, or an increase in the proportion of other
14
gases such as carbon dioxide or nitrogen;
15
(c)
PACKAGING
material or the respiration of the
Controlled atmosphere
Modified
in which the atmosphere of a
16
PACKAGE
17
composition is different from air, and continuous control of that
18
atmosphere is maintained, such as by using oxygen cavengers or a
19
combination of total replacement of oxygen, nonrespiring FOOD, and
20
impermeable PACKAGING material;
21
(d)
of
PACKAGING,
FOOD.
Cook chill
FOOD
is modified so that until the PACKAGE is opened, its
PACKAGING,
in which cooked
FOOD
is hot filled into
22
impermeable bags which have the air expelled and are then sealed or
23
crimped closed. The bagged FOOD is rapidly chilled and refrigerated
24
at temperatures that inhibit the growth of psychotropic pathogens; or
25
(e)
Sous vide PACKAGING, in which raw or partially cooked FOOD is placed
26
in a hermetically sealed, impermeable bag, cooked in the bag, rapidly
27
chilled, and refrigerated at temperatures that inhibit the growth of
28
psychotropic pathogens.
29
“Refuse” means solid waste not carried by water through the SEWAGE system.
20
1
04.05.11
“Regulatory authority” means the Department of Public Health and Social
2
Services and its authorized representatives having jurisdiction over the
3
ESTABLISHMENT.
4
“Reminder” means a written statement concerning the health RISK of consuming
5
animal FOODS raw, undercooked, or without otherwise being processed to eliminate
6
pathogens.
7
“Re-service” means the transfer of
8
CONSUMER
9
another PERSON.
FOOD
FOOD
that is unused and returned by a
after being served or sold and in the possession of the
CONSUMER,
to
10
“Restrict” means to limit activities of
11
transmitting a disease that is transmissible through
12
does not work with exposed FOOD, clean EQUIPMENT, UTENSILS, LINENS, or unwrapped
13
SINGLE-SERVICE
14
“Restricted egg” means any check, dirty EGG, incubator reject, inedible, leaker, or
15
loss as defined in 9 CFR 590.
16
“Restricted use pesticide” means a pesticide product that contains the active
17
ingredients specified in 40 CFR 152.175 Pesticides classified for restricted use, and
18
that is limited to use by or under the direct supervision of a certified applicator.
19
“Risk” means the likelihood that an adverse health effect will occur within a
20
population as a result of a HAZARD in a FOOD.
21
“Safe material” means:
22
(1)
FOOD EMPLOYEE
so that there is no
FOOD
and the
RISK
of
FOOD EMPLOYEE
or SINGLE-USE ARTICLES.
An article manufactured from or composed of materials that may not
23
reasonably be expected to result, directly or indirectly, in their becoming a
24
component or otherwise affecting the characteristics of any FOOD;
25
(2)
26
27
28
An additive that is used as specified in § 409 or 706 of the Federal Food,
Drug, and Cosmetic Act; or
(3)
Other materials that are not
ADDITIVES
and that are used in conformity with
applicable regulations of the Food and Drug Administration.
29
“Sanitization” means the application of cumulative heat or chemicals on cleaned
30
FOOD-CONTACT SURFACES
that, when evaluated for efficacy, is sufficient to yield a
21
1
04.05.11
reduction of 5 logs, which is equal to a 99.999% reduction, of representative
2
disease microorganisms of public health importance.
3
“Sealed” means free of cracks or other openings that allow the entry or passage of
4
moisture.
5
“Service animal” means an animal such as a guide dog, signal dog, or other
6
animal individually trained to provide assistance to an individual with a disability.
7
“Servicing area” means an operating base location to which a mobile
8
ESTABLISHMENT or transportation vehicle
9
and equipment cleaning, discharging liquid or solid wastes, refilling water tanks and
FOOD
returns regularly for such things as vehicle
10
ice bins, and boarding FOOD.
11
“Sewage” means liquid waste containing animal or vegetable matter in suspension
12
or solution and may include liquids containing chemicals in solution.
13
“Shellfish control authority” means a state, federal, foreign, tribal, or other
14
government entity legally responsible for administering a program that includes
15
certification of
16
commerce.
17
“Shellstock” means raw, in-shell MOLLUSCAN SHELLFISH.
18
“Shiga toxin-producing Escherichia coli” (STEC) means any E. coli capable of
19
producing Shiga toxins (also called verocytotoxins or “Shiga-like” toxins).
20
Examples of serotypes of STEC include both O157 and non-O157 E. coli. Also
21
see ENTEROHEMORRHAGIC ESCHERICHIA COLI.
22
“Shucked shellfish” means
23
removed.
24
“Single-service articles” means TABLEWARE, carry-out UTENSILS, and other items
25
such as bags, containers, placemats, stirrers, straws, toothpicks, and wrappers that
26
are designed and constructed for one time, one
27
intended for discard.
28
Single-Use Articles.
29
(1)
30
MOLLUSCAN SHELLFISH
harvesters and
MOLLUSCAN SHELLFISH
DEALERS
for interstate
that have one or both shells
PERSON
use after which they are
“Single-use articles” means UTENSILS and bulk FOOD containers designed
and constructed to be used once and discarded.
22
1
(2)
04.05.11
“Single-use articles” includes items such as wax paper, butcher paper,
2
plastic wrap, formed aluminum FOOD containers, jars, plastic tubs or buckets,
3
bread wrappers, pickle barrels, ketchup bottles, and number 10 cans which
4
do not meet the materials, durability, strength, and cleanability specifications
5
under Sections 4-101.11, 4-201.11, and 4-202.11 for multiuse UTENSILS.
6
“Slacking” means the process of moderating the temperature of a FOOD such as
7
allowing a FOOD to gradually increase from a temperature of -23oC (-10oF) to -4oC
8
(25oF) in preparation for deep-fat frying or to facilitate even heat penetration during
9
the cooking of previously block-frozen FOOD such as shrimp.
10
“Smooth” means:
11
(1)
12
13
cleanability equal to or exceeding that of (100 grit) number 3 stainless steel;
(2)
14
15
A FOOD-CONTACT SURFACE having a surface free of pits and inclusions with a
A nonFOOD-CONTACT SURFACE of EQUIPMENT having a surface equal to that of
commercial grade hot-rolled steel free of visible scale; and
(3)
16
A floor, wall, or ceiling having an even or level surface with no roughness or
projections that render it difficult to clean.
17
“Tableware” means eating, drinking, and serving
18
flatware including forks, knives, and spoons; hollowware including bowls, cups,
19
serving dishes, and tumblers; and plates.
20
“Temperature measuring device” means a thermometer, thermocouple,
21
thermistor, or other device that indicates the temperature of FOOD, air, or water.
22
Temporary food establishment.
23
(1)
UTENSILS
“Temporary food establishment” means a
for table use such as
FOOD ESTABLISHMENT
that
24
operates for a period of no more than 14 consecutive days in conjunction
25
with a single event or celebration.
26
27
(2)
“Temporary food establishment” does not include:
(a)
A “temporary food service establishment” that is referenced in §
28
21102(f) of Chapter 21, Title 10 GCA, and is defined as a
29
ESTABLISHMENT,
FOOD
that operates for a period of no more than 180
23
1
04.05.11
consecutive days in conjunction with a single event or celebration
2
which shall meet all the requirements of this Code; or
3
(b)
Any other FOOD ESTABLISHMENT that operates for a period of no more
than 180 consecutive days but less than 365 consecutive days.
4
5
“USDA” means the U.S. Department of Agriculture.
6
“Utensil” means a
7
preparation, transportation, dispensing, sale, or service of
8
KITCHENWARE or TABLEWARE
9
used in contact with
FOOD-CONTACT
implement or container used in the storage,
FOOD,
such as
that is multiuse, SINGLE-SERVICE, or SINGLE-USE; gloves
FOOD;
temperature sensing probes of
FOOD TEMPERATURE
10
MEASURING DEVICES;
and probe-type price or identification tags used in contact with
11
FOOD.
12
“Variance” means a written document issued by the REGULATORY AUTHORITY that
13
authorizes a modification or waiver of one or more requirements of this Code if, in
14
the opinion of the
15
result from the modification or waiver.
16
“Vending machine” means a self-service device that, upon insertion of a coin,
17
paper currency, token, card, or key, or by optional manual operation, dispenses
18
unit servings of FOOD in bulk or in packages without the necessity of replenishing
19
the device between each vending operation.
20
“Vending machine location” means the room, enclosure, space, or area where
21
one or more VENDING MACHINES are installed and operated and includes the storage
22
areas and areas on the PREMISES that are used to service and maintain the VENDING
23
MACHINES.
24
“Warewashing” means the cleaning and SANITIZING of UTENSILS and FOOD-
25
CONTACT SURFACES
26
“Whole-muscle, intact beef” means whole muscle beef that is not injected,
27
mechanically tenderized, reconstructed, or scored and marinated, from which
28
beef steaks may be cut.
REGULATORY AUTHORITY,
a health
HAZARD
or nuisance will not
of EQUIPMENT.
24
04.05.11
1
Chapter
2
2
3
Parts
Management and Personnel
4
2-1
SUPERVISION
5
2-2
EMPLOYEE HEALTH
6
2-3
PERSONAL CLEANLINESS
7
2-4
HYGIENIC PRACTICES
8
2-1
SUPERVISION
9
Subparts
10
2-101
Responsibility
11
2-102
Knowledge
12
2-103
Duties
2-101.11
Assignment.*
13
Responsibility
14
(A)
Except as specified in ¶ (B) of this section, the PERMIT HOLDER
15
shall be the
16
CHARGE and shall
17
the FOOD ESTABLISHMENT during all hours of operation.
18
(B)
PERSON IN CHARGE
or shall designate a PERSON IN
ensure that a PERSON IN CHARGE is present at
In a FOOD ESTABLISHMENT with two or more separately PERMITTED
19
departments that are the legal responsibility of the same
20
PERMIT HOLDER
and that are located on the same PREMISES, the
21
PERMIT HOLDER
may, during specific time periods when food is
22
not being prepared, packaged, or served, designate a single
23
PERSON IN CHARGE
24
hours of operation, and who is responsible for each separately
25
PERMITTED FOOD ESTABLISHMENT
26
Knowledge
2-102.11
who is present on the
PREMISES
during all
on the PREMISES.
Demonstration.*
27
Based on the RISKS inherent to the FOOD operation, during inspections
28
and upon request the
PERSON IN CHARGE
25
shall demonstrate to the
04.05.11
knowledge of foodborne disease prevention,
1
REGULATORY AUTHORITY
2
application of the HAZARD Analysis and CRITICAL CONTROL POINT
3
principles, and the requirements of this Code. The PERSON IN CHARGE
4
shall demonstrate this knowledge by:
5
(A)
6
7
Complying with this Code by having no violations of
ITEMS
(B)
CRITICAL
during the current inspection;
Being a certified
FOOD
protection manager who has shown
8
proficiency of required information through passing a test that
9
is part of an ACCREDITED PROGRAM; or
10
(C)
Responding correctly to the inspector's questions as they
11
relate to the specific FOOD operation. The areas of knowledge
12
include:
13
(1)
Describing the relationship between the prevention of
14
foodborne disease and the personal hygiene of a FOOD
15
EMPLOYEE;
16
(2)
Explaining the responsibility of the PERSON IN CHARGE for
17
preventing the transmission of foodborne disease by a
18
FOOD EMPLOYEE who has a disease or medical
19
that may cause foodborne disease;
20
(3)
21
22
Describing the symptoms associated with the diseases
that are transmissible through FOOD;
(4)
Explaining the significance of the relationship between
23
maintaining the time and temperature of
24
HAZARDOUS
25
SAFETY FOOD)
26
(5)
27
28
condition
FOOD
(TIME/TEMPERATURE
POTENTIALLY
CONTROL FOR
and the prevention of foodborne illness;
Explaining the HAZARDS involved in the consumption of
raw or undercooked MEAT, POULTRY, EGGS, and FISH:
(6)
Stating the required
cooking
temperatures and times for
29
safe
30
(TIME/TEMPERATURE CONTROL FOR SAFETY FOOD) including
26
of
FOOD
POTENTIALLY
HAZARDOUS
FOOD
04.05.11
1
2
MEAT, POULTRY, EGGS,
(7)
and
FISH;
Stating the required temperatures
and times for
3
the safe refrigerated storage, hot holding, cooling,
4
and
5
(TIME/TEMPERATURE CONTROL FOR SAFETY FOOD);
6
(8)
reheating
of
POTENTIALLY
HAZARDOUS
FOOD
Describing the relationship between the prevention of
7
foodborne illness and the management and control of
8
the following:
9
(a)
Cross contamination,
10
(b)
Hand contact with READY-TO-EAT FOODS,
11
(c)
Handwashing, and
12
(d)
Maintaining the
13
14
FOOD ESTABLISHMENT
in a clean
condition and in good repair;
(9)
Describing
FOODS
identified as
MAJOR FOOD ALLERGENS
15
and the symptoms that a
16
cause in a sensitive individual who has an allergic
17
reaction.
18
(10)
MAJOR FOOD ALLERGEN
Explaining the relationship between
FOOD
safety and
19
providing EQUIPMENT that is:
20
(a)
Sufficient in number and capacity, and
21
(b)
Properly
22
23
designed,
located,
installed, operated, maintained, and cleaned;
(11)
Explaining correct procedures for cleaning and
24
SANITIZING UTENSILS
25
EQUIPMENT;
26
constructed,
could
(12)
and
FOOD-CONTACT SURFACES
of
Identifying the source of water used and measures
27
taken to ensure that it remains protected from
28
contamination such as providing protection from
29
backflow and precluding the creation of cross
30
connections;
27
1
(13)
Identifying
POISONOUS OR TOXIC MATERIALS
04.05.11
in the FOOD
2
ESTABLISHMENT and the procedures necessary to ensure
3
that they are safely stored, dispensed, used, and
4
disposed of according to LAW;
5
(14)
Identifying
CRITICAL CONTROL POINTS
in the operation
6
from purchasing through sale or service that when not
7
controlled may contribute to the transmission of
8
foodborne illness and explaining steps taken to ensure
9
that the points are controlled in accordance with the
10
requirements of this Code;
11
(15)
Explaining the details of how the PERSON IN CHARGE and
12
FOOD EMPLOYEES comply with the HACCP PLAN
13
is required by the
14
between the
15
ESTABLISHMENT;
16
(16)
LAW ,
this Code, or an agreement
REGULATORY AUTHORITY
assigned by this Code to the:
18
(a)
FOOD EMPLOYEE,
19
(b)
CONDITIONAL EMPLOYEE,
20
(c)
PERSON IN CHARGE,
21
(d)
REGULATORY AUTHORITY; and
(17)
and the
FOOD
Explaining the responsibilities, rights, and authorities
17
22
if a plan
Explaining how the PERSON IN CHARGE, FOOD EMPLOYEES,
23
and
24
responsibilities and EXCLUSION or RESTRICTION of FOOD
25
EMPLOYEES.
CONDITIONAL EMPLOYEES
comply with reporting
26
2-102.20
Food Protection Manager Certification.
27
A
28
protection manager that is certified by a
29
certification program that is evaluated and listed by a Conference for
30
Food Protection-recognized accrediting agency as conforming to the
PERSON IN CHARGE
who demonstrates knowledge by being a
28
FOOD
FOOD
protection manager
1
04.05.11
Conference for Food Protection Standards for Accreditation of Food
2
Protection Manager Certification Programs is deemed to comply with
3
¶ 2-102.11(B), or a similar program approved by the
4
AUTHORITY.
5
Duties
2-103.11
REGULATORY
Person in Charge.
6
The PERSON IN CHARGE shall ensure that:
7
(A)
FOOD ESTABLISHMENT operations are not conducted in a private
8
home or in a room used as living or sleeping quarters as
9
specified under §6-202.111;
10
PERSONS unnecessary to the
FOOD ESTABLISHMENT
11
are not allowed in the
preparation,
12
WAREWASHING
13
authorized by the
14
ensure that exposed
15
LINENS;
and unwrapped
16
ARTICLES
are protected from contamination;
17
(B)
(C)
PERSON IN CHARGE
FOOD;
EMPLOYEES and other
maintenance
19
FOOD
20
comply with this Code;
(D)
22
23
FOOD
storage, or
areas, except that brief visits and tours may be
18
21
FOOD
operation
PERSONS
preparation,
clean
if steps are taken to
EQUIPMENT, UTENSILS,
SINGLE-SERVICE
PERSONS
and
and
SINGLE-USE
such as delivery and
and pesticide applicators entering the
FOOD
storage, and
WAREWASHING
areas
EMPLOYEES are effectively cleaning their hands, by routinely
monitoring the EMPLOYEES' handwashing;
(E)
EMPLOYEES are visibly observing FOODS as they are received to
24
determine that they are from APPROVED sources, delivered at
25
the required temperatures, protected from contamination,
26
unADULTERATED, and accurately presented, by routinely
27
monitoring the
28
evaluating FOODS upon their receipt;
29
30
(F)
EMPLOYEES'
observations and periodically
EMPLOYEES are properly cooking POTENTIALLY HAZARDOUS FOOD
(TIME/TEMPERATURE
29
CONTROL
FOR
SAFETY
FOOD),
being
04.05.11
known to cause
1
particularly careful in cooking those
2
severe foodborne illness and death, such as
3
COMMINUTED MEATS,
4
routine monitoring of the cooking temperatures using
5
appropriate temperature measuring devices properly scaled
6
and calibrated as specified under §4-203.11 and ¶
7
4-502.11(B);
8
(G)
9
FOODS
EGGS
through daily oversight of the EMPLOYEES'
EMPLOYEES are using proper methods to rapidly cool
POTENTIALLY HAZARDOUS FOODS (TIME/TEMPERATURE CONTROL FOR
10
SAFETY FOODS)
11
within 4 hours, through daily oversight of the
12
routine monitoring of FOOD temperatures during cooling;
13
and
(H)
that are not held hot or are not for consumption
CONSUMERS who order raw or partially cooked
EMPLOYEES'
READY-TO-EAT
14
FOODS
15
3-603.11 that the FOOD is not cooked sufficiently to ensure its
16
safety;
17
(I)
of animal origin are informed as specified under §
EMPLOYEES are properly SANITIZING cleaned multiuse EQUIPMENT
18
and
19
monitoring of solution temperature and exposure time for hot
20
water SANITIZING, and chemical concentration, pH, temperature,
21
and exposure time for chemical
22
(J)
UTENSILS
before they are reused, through routine
SANITIZING;
CONSUMERS are notified that clean
TABLEWARE
is to be used
23
when they return to self-service areas such as salad bars and
24
buffets as specified under § 3-304.16;
25
(K)
Except when
APPROVAL
is obtained from the
as specified in ¶ 3-301.11(D),
REGULATORY
26
AUTHORITY
27
preventing cross-contamination of
28
bare hands by properly using suitable
29
tissue, spatulas, tongs, single-use gloves, or dispensing
30
EQUIPMENT;
30
EMPLOYEES
are
READY-TO-EAT FOOD
with
UTENSILS
such as deli
1
(L)
2
04.05.11
EMPLOYEES are properly trained in FOOD safety as it relates to
their assigned duties; and
3
(M)
FOOD EMPLOYEES and CONDITIONAL EMPLOYEES are informed of
4
their responsibility to report in accordance with
LAW ,
to the
5
PERSON IN CHARGE, information about their health and activities
6
as they relate to diseases that are transmissible through FOOD,
7
as specified under ¶ 2-201.11(A).
8
9
2-2
10
EMPLOYEE HEALTH
Subpart
11
2-201
Responsibilities of Permit Holder, Person in
12
Charge,
Food
13
Employees.*
Employees,
and
Conditional
14
Responsibilities 2-201.11
Responsibility of Permit Holder, Person Charge,
15
and Reporting
Conditional Employees.*
16
Symptoms
17
and Diagnosis
(A)
The
PERMIT HOLDER
(CONDITIONAL
shall require FOOD EMPLOYEES and
EMPLOYEES
to report to the
PERSON IN CHARGE
18
information about their health and activities as they relate to
19
diseases that are transmissible through
20
EMPLOYEE or CONDITIONAL EMPLOYEE shall
21
in a manner that allows the
22
RISK
23
necessary additional information, such as the date of onset of
24
symptoms and an illness, or of a diagnosis without symptoms if
25
the FOOD EMPLOYEE or CONDITIONAL EMPLOYEE:
26
reportable symptoms
(1)
FOOD.
A
FOOD
report the information
PERSON IN CHARGE
to reduce the
of foodborne disease transmission, including providing
Has any of the following symptoms:
27
(a)
Vomiting,
28
(b)
Diarrhea,
29
(c)
Jaundice,
30
(d)
Sore throat with fever, or
31
1
(e)
04.05.11
A lesion containing pus such as a boil or
2
infected wound that is open or draining and is:
3
(i)
On the hands or wrists, unless an
4
impermeable cover such as a finger cot or
5
stall protects the lesion and a SINGLE-USE
6
glove is worn over the impermeable
7
cover,
8
(ii)
9
On exposed portions of the arms, unless
the lesion is protected by an impermeable
10
cover, or
11
(iii)
On other parts of the body, unless the
12
lesion is covered by a dry, durable, tight-
13
fitting bandage;
14
reportable
15
diagnosis
(2)
Has an illness diagnosed by a
HEALTH PRACTITIONER
due to:
16
(a)
Norovirus,
17
(b)
Hepatitis A virus,
18
(c)
Shigella spp.,
19
(d)
ENTEROHEMORRHAGIC or SHIGA TOXIN-PRODUCING
20
ESCHERICHIA COLI, or
21
(e)
22
reportable
23
past illness
(3)
Salmonella Typhi;
Had a previous illness, diagnosed by a
HEALTH PRACTITIONER,
within the past 3 months due to
24
Salmonella Typhi, without having received antibiotic
25
therapy, as determined by a HEALTH PRACTITIONER;
26
reportable
(4)
Has been exposed to, or is the suspected source
27
history of
of, a CONFIRMED DISEASE OUTBREAK, because the
28
exposure
FOOD EMPLOYEE
or CONDITIONAL EMPLOYEE consumed or
29
prepared FOOD implicated in the outbreak, or consumed
30
FOOD at
an event prepared by a PERSON who is infected
32
04.05.11
1
or ill with:
2
(a)
3
Norovirus within the past 48 hours of the last
exposure,
4
(b)
ENTEROHEMORRHAGIC or SHIGA TOXIN-PRODUCING
5
ESCHERICHIA COLI, or Shigella spp. within the past
6
3 days of the last exposure,
7
(c)
8
Salmonella Typhi within the past 14 days of the
last exposure, or
9
(d)
10
Hepatitis A virus within the past 30 days of the
last exposure; or
11
reportable
5)
Has been exposed by attending or working in a
12
history of
setting where there is a CONFIRMED DISEASE
13
exposure
OUTBREAK,
or living in the same household as, and has
14
knowledge about, an individual who works or attends a
15
setting where there is a
16
or living in the same household as, and has knowledge
17
about, an individual diagnosed with an illness caused
18
by:
19
(a)
20
CONFIRMED DISEASE OUTBREAK,
Norovirus within the past 48 hours of the last
exposure,
21
(b)
ENTEROHEMORRHAGIC or SHIGA TOXIN-PRODUCING
22
ESCHERICHIA COLI, or Shigella spp. within the past
23
3 days of the last exposure,
24
(c)
25
Salmonella Typhi within the past 14 days of the
last exposure, or
26
(d)
27
Hepatitis A virus within the past 30 days of the
last exposure.
28
responsibility of
(B)
The PERSON IN CHARGE shall notify the REGULATORY
29
person in charge
AUTHORITY
30
to notify the
(1)
when a FOOD EMPLOYEE is:
Jaundiced, or
33
1
regulatory authority
(2)
04.05.11
Diagnosed with an illness due to a pathogen as
2
specified under Subparagraphs (A)(2)(a) - (e) of this
3
section.
4
responsibility of
(C)
The PERSON IN CHARGE shall ensure that a CONDITIONAL
5
the person in charge
EMPLOYEE:
6
to prohibit a conditional
(1)
7
employee from becoming
a diagnosed illness as specified under
8
a food employee
Subparagraphs (A)(1) - (3) of this section, is prohibited
9
Who exhibits or reports a symptom, or who reports
from becoming a
FOOD EMPLOYEE
until the
CONDITIONAL
10
EMPLOYEE
11
or diagnosed illness as specified under § 2-201.13; and
12
(2)
meets the criteria for the specific symptoms
Who will work as a
FOOD EMPLOYEE
13
ESTABLISHMENT
14
POPULATION
15
specified
16
prohibited from becoming a
17
CONDITIONAL EMPLOYEE
18
under ¶ 2-201.13(I).
(D)
that serves as a
in a
FOOD
HIGHLY SUSCEPTIBLE
and reports a history of exposure as
under
Subparagraphs
(A)(4) – (5),
FOOD EMPLOYEE
is
until the
meets the criteria as specified
19
responsibility of
The PERSON IN CHARGE shall ensure that a FOOD EMPLOYEE
20
the person in charge
who exhibits or reports a symptom, or who reports a
21
to exclude or restrict
diagnosed illness or a history of exposure as specified
22
under Subparagraphs (A)(1) - (5) of this section is:
23
(1)
EXCLUDED as specified under ¶¶ 2-201.12 (A) - (C), and
24
Subparagraphs (D)(1), (E)(1), (F)(1), or (G)(1) and in
25
compliance with the provisions specified under
26
¶¶ 2-201.13(A) - (G); or
27
(2)
RESTRICTED as specified under Subparagraphs 2-
28
201.12 (D)(2), (E)(2), (F)(2), (G)(2), or ¶¶ 2-201.12(H)
29
or (I) and in compliance with the provisions specified
30
under ¶¶ 2-201.13(D) - (I).
34
(E)
04.05.11
A FOOD EMPLOYEE or CONDITIONAL EMPLOYEE shall report to
1
responsibility of
2
food employees and
the PERSON IN CHARGE the information as specified under
3
conditional
¶ (A) of this section.
4
employees to report
5
6
responsibility of
7
food employees
8
to comply
(F)
A FOOD EMPLOYEE shall:
(1)
Comply with an EXCLUSION as specified under
¶¶ 2-201.12(A)-(C) and Subparagraphs 2-201.12(D)(1),
9
(E)(1), (F)(1), or (G)(1) and with the provisions
10
specified under ¶¶ 2-201.13(A) - (G); or
11
(2)
Comply with a
RESTRICTION
as specified under
12
Subparagraphs 2-201.12(D)(2), (E)(2), (F)(2), (G)(2), or
13
¶¶ 2-201.12 (H) or (I) and comply with the provisions
14
specified under ¶¶ 2-201.13(D) - (I).
15
conditions of
2-201.12
16
exclusion
The PERSON IN CHARGE shall
17
and restriction
EMPLOYEE
18
Exclusions and Restrictions.*
from a
EXCLUDE
or RESTRICT a FOOD
FOOD ESTABLISHMENT
in accordance with the
following:
19
20
Symptomatic
(A)
Except when the symptom is from a noninfectious
21
with vomiting
condition, EXCLUDE a FOOD EMPLOYEE if the
22
or diarrhea
EMPLOYEE is:
FOOD
23
(1)
Symptomatic with vomiting or diarrhea; or
24
(2)
Symptomatic with vomiting or diarrhea and diagnosed
25
with an infection from Norovirus, Shigella spp., or
26
ENTEROHEMORRHAGIC or SHIGA TOXIN-PRODUCING E. COLI.
27
jaundiced or
(B)
ExCLUDE a FOOD EMPLOYEE who is:
28
diagnosed
29
with hepatitis A
the last 7 calendar days, unless the FOOD EMPLOYEE
30
infection
provides to the
(1)
Jaundiced and the onset of jaundice occurred within
35
PERSON IN CHARGE
written medical
04.05.11
specifying
1
documentation from a
2
that the jaundice is not caused by hepatitis A virus or
3
other fecal-orally transmitted infection;
4
(2)
HEALTH PRACTITIONER
Diagnosed with an infection from hepatitis A virus within
5
14 calendar days from the onset of any illness
6
symptoms, or within 7 calendar days of the onset of
7
jaundice; or
8
(3)
9
Diagnosed with an infection from hepatitis A virus
without developing symptoms.
10
diagnosed or
(C)
EXCLUDE a FOOD EMPLOYEE who is diagnosed with
11
reported previous
an infection from Salmonella Typhi, or reports a
12
infection due
previous infection with Salmonella Typhi within the past
13
to S. Typhi
3 months as specified under Subparagraph 2-201.11(A)(3).
14
15
diagnosed with
(D)
16
an
Norovirus and is ASYMPTOMATIC:
17
asymptomatic
(1)
18
infection from
ESTABLISHMENT
19
Norovirus
POPULATION;
20
If a
(2)
FOOD EMPLOYEE is
EXCLUDE the FOOD EMPLOYEE who works in a FOOD
serving a
HIGHLY SUSCEPTIBLE
or
RESTRICT the
FOOD EMPLOYEE
21
ESTABLISHMENT
22
POPULATION.
who works in a
not serving a
23
diagnosed with
24
Shigella
Shigella spp. and is ASYMPTOMATIC:
25
spp. infection
(1)
26
and
FOOD ESTABLISHMENT serving
27
asymptomatic
POPULATION;
28
(E)
diagnosed with an infection from
FOOD
HIGHLY SUSCEPTIBLE
If a FOOD EMPLOYEE is diagnosed with an infection from
(2)
EXCLUDE the
FOOD EMPLOYEE
a HIGHLY SUSCEPTIBLE
or
RESTRICT the
FOOD EMPLOYEE
29
ESTABLISHMENT
30
POPULATION.
36
who works in a
who works in a
not serving a
FOOD
HIGHLY SUSCEPTIBLE
1
diagnosed with
2
EHEC
3
or STEC and
4
asymptomatic
04.05.11
If a FOOD EMPLOYEE is diagnosed with an infection from
(F)
ENTEROHEMORRHAGIC or SHIGA TOXIN-PRODUCING E. COLI, and
is
ASYMPTOMATIC:
(1)
EXCLUDE the
FOOD EMPLOYEE
5
ESTABLISHMENT
6
POPULATION;
7
(2)
RESTRICT the
FOOD EMPLOYEE
ESTABLISHMENT
9
POPULATION.
10
symptomatic with
11
sore throat with
sore throat with fever:
12
fever
(1)
EXCLUDE the
SUSCEPTIBLE
who works in a
not serving a
FOOD
HIGHLY SUSCEPTIBLE
14
POPULATION;
(2)
serving
a
HIGHLY
FOOD
SUSCEPTIBLE
or
RESTRICT the
FOOD EMPLOYEE
16
ESTABLISHMENT
17
POPULATION.
If a
who works in a
FOOD EMPLOYEE
ESTABLISHMENT
(H)
HIGHLY
If a FOOD EMPLOYEE is ill with symptoms of acute onset of
13
15
a
FOOD
or
8
(G)
serving
who works in a
who works in a
not serving a
FOOD
HIGHLY SUSCEPTIBLE
18
symptomatic with
19
uncovered
containing pus such as a boil or infected wound that is
20
infected
open or draining and not properly covered as specified
21
wound or pustular
under Subparagraph 2-201.11(A)(1)(e), RESTRICT the
22
boil
EMPLOYEE.
FOOD EMPLOYEE
is infected with a skin lesion
FOOD
23
24
exposed to
(I)
If a FOOD EMPLOYEE is exposed to a foodborne pathogen
25
foodborne
as specified under Subparagraphs 2-201.11(A)(4) or (5),
26
pathogen and
RESTRICT
27
works in food
LISHMENT serving
28
establishment
29
serving HSP
the
FOOD EMPLOYEE
who works in a FOOD ESTA-
a HIGHLY SUSCEPTIBLE POPULATION.
30
37
2-201.13
04.05.11
Removal, Adjustment, or Retention of Exclusions
1
Managing
2
Exclusions
3
and
The PERSON IN
4
Restrictions
when removing, adjusting, or retaining the EXCLUSION or RESTRICTION
and Restrictions.
CHARGE
5
of a FOOD EMPLOYEE:
6
(A)
Except when a
shall adhere to the following conditions
FOOD EMPLOYEE
is diagnosed with an infection
from hepatitis A virus or Salmonella Typhi:
7
8
removing exclusion
(1)
9
for food employee
specified under Subparagraph 2-201.12(A)(1) if the
10
who was symptomatic
FOOD EMPLOYEE:
11
and not diagnosed
(a)
12
Reinstate a FOOD EMPLOYEE who was EXCLUDED as
Is ASYMPTOMATIC for at least 24 hours; or
b)
Provides to the PERSON IN CHARGE written medical
13
documentation from a HEALTH PRACTITIONER that
14
states the symptom is from a noninfectious
15
condition.
16
Norovirus diagnosis
(2)
If a
FOOD EMPLOYEE
was diagnosed with an infection
17
from Norovirus and
18
Subparagraph 2-201.12(A)(2):
(a)
RESTRICT the
EXCLUDED
as specified under
19
adjusting exclusion for
FOOD EMPLOYEE,
who is
20
food employee who
ASYMPTOMATIC
21
was symptomatic and
in a FOOD ESTABLISHMENT not serving a HIGHLY
22
is now asymptomatic
SUSCEPTIBLE POPULATION,
for at least 24 hours and works
until the conditions for
23
reinstatement as specified under Subparagraphs
24
(D)(1) or (2) of this section are met; or
25
retaining exclusion for
(b)
Retain the EXCLUSION for the FOOD EMPLOYEE,
26
food employee who
who is
27
was asymptomatic
and works in a
28
and is now asymptomatic
serves a
29
and works in food
until the conditions for reinstatement as
30
establishment serving HSP
specified under Subparagraphs (D)(1) or (2) of
38
ASYMPTOMATIC
for at least 24 hours
FOOD ESTABLISHMENT
that
HIGHLY SUSCEPTIBLE POPULATION,
04.05.11
1
this section are met.
2
Shigella spp.
3
Diagnosis
(3)
If a FOOD EMPLOYEE was diagnosed with an infection
from Shigella spp. and
EXCLUDED
as specified under
Subparagraph 2-201.12(A)(2):
4
5
adjusting exclusion for
(a)
6
food employee who
ASYMPTOMATIC
7
was symptomatic and
in a FOOD ESTABLISHMENT not serving a HIGHLY
8
is now asymptomatic
SUSCEPTIBLE POPULATION,
9
RESTRICT the
FOOD EMPLOYEE,
who is
for at least 24 hours and works
until the conditions for
reinstatement as specified under Subparagraphs
10
(E)(1) or (2) of this section are met; or
11
retaining exclusion for
(b)
Retain the EXCLUSION for the FOOD EMPLOYEE,
12
food employee who
who is ASYMPTOMATIC for at least 24 hours and
13
was asymptomatic and
works in a FOOD ESTABLISHMENT that serves a
14
is now asymptomatic
HIGHLY
SUSCEPTIBLE
POPULATION,
until
the
15
conditions for reinstatement as specified under
16
Subparagraphs (E)(1) or (2) , or (E)(1) and (3)(a)
17
of this section are met.
18
EHEC or STEC
19
Diagnosis
(4)
If a FOOD EMPLOYEE was diagnosed with an infection
from ENTEROHEMORRHAGIC or SHIGA
20
ESCHERICHIA
21
Subparagraph 2-201.12(A)(2):
22
adjusting exclusion for
23
(a)
COLI
and
EXCLUDED
TOXIN- PRODUCING
as specified under
RESTRICT the
FOOD EMPLOYEE,
who is
food employee who
ASYMPTOMATIC
for at least 24 hours and
24
was symptomatic and
works in a
25
is now asymptomatic
a
FOOD ESTABLISHMENT not
serving
HIGHLY SUSCEPTIBLE POPULATION,
until the
26
conditions for reinstatement as specified under
27
Subparagraphs (F)(1) or (2) of this section are
28
met; or
29
retaining exclusion
30
for food employee
(b)
Retain the EXCLUSION for the FOOD EMPLOYEE,
who is ASYMPTOMATIC for at least 24 hours and
39
1
who was symptomatic
04.05.11
works in a FOOD ESTABLISHMENT that serves
2
and is now asymptomatic
a
3
and works in food
conditions for reinstatement as specified under
4
establishment serving HSP
Subparagraphs (F)(1) or (2) are met.
HIGHLY SUSCEPTIBLE POPULATION,
until the
5
6
hepatitis A virus
(B)
Reinstate a FOOD EMPLOYEE who was EXCLUDED as specified
7
or jaundice
under ¶ 2-201.12(B) if the
8
diagnosis –
APPROVAL
9
removing
following conditions is met;
10
exclusions
(1)
11
PERSON IN CHARGE
obtains
from the REGULATORY AUTHORITY and one of the
The FOOD EMPLOYEE has been jaundiced for more than 7
calendar days;
12
(2)
The anicteric
FOOD EMPLOYEE
has been symptomatic
13
with symptoms other than jaundice for more than 14
14
calendar days; or
15
(3)
The
FOOD EMPLOYEE
written
17
PRACTITIONER stating that the FOOD EMPLOYEE is free of a
18
hepatitis A virus infection.
Reinstate a
documentation
PERSON IN CHARGE
16
(C)
medical
provides to the
19
S. Typhi
20
diagnosis –
(specified under ¶ 2-201.12(C) if:
21
removing
(1)
22
exclusions
FOOD EMPLOYEE
(2)
a
EXCLUDED
HEALTH
as
The PERSON IN CHARGE obtains APPROVAL from the
REGULATORY AUTHORITY;
23
who was
from
The
FOOD EMPLOYEE
provides to the
written
25
PRACTITIONER that states the FOOD EMPLOYEE is free from
26
S. Typhi infection.
Reinstate a
documentation
PERSON IN CHARGE
24
(D)
medical
and
FOOD EMPLOYEE who
a
HEALTH
27
Norovirus
28
diagnosis –
specified under Subparagraphs 2-201.12(A)(2) or (D)(1) who
29
removing
was
30
exclusion
PERSON IN CHARGE obtains APPROVAL from
RESTRICTED
was
from
EXCLUDED
as
under Subparagraph 2-201.12(D)(2) if the
40
the REGULATORY
1
or restriction
AUTHORITY
2
(1)
04.05.11
and one of the following conditions is met:
The EXCLUDED or RESTRICTED FOOD EMPLOYEE provides to
3
the
4
from a
5
EMPLOYEE
6
(2)
PERSON IN CHARGE
written medical documentation
HEALTH PRACTITIONER
stating that the
FOOD
is free of a Norovirus infection;
The FOOD EMPLOYEE was EXCLUDED or RESTRICTED after
7
symptoms of vomiting or diarrhea resolved, and more
8
than 48 hours have passed since the
9
became
10
(3)
The
ASYMPTOMATIC;
FOOD EMPLOYEE
FOOD EMPLOYEE
or
was
EXCLUDED
or
RESTRICTED
and
11
did not develop symptoms and more than 48 hours
12
have passed since the FOOD EMPLOYEE was diagnosed.
13
Shigella spp.
14
diagnosis –
under Subparagraphs 2-201.12(A)(2) or (E)(1) or who was
15
removing
RESTRICTED
16
exclusion or
IN CHARGE
17
restriction
and one of the following conditions is met:
18
(E)
Reinstate a FOOD EMPLOYEE who was EXCLUDED as specified
(1)
under Subparagraph 2-201.12(E)(2) if the PERSON
obtains APPROVAL from the REGULATORY AUTHORITY
The EXCLUDED or RESTRICTED FOOD EMPLOYEE provides to
19
the
20
from a
21
EMPLOYEE
22
test results showing 2 consecutive negative stool
23
specimen cultures that are taken:
24
(a)
25
written medical documentation
HEALTH PRACTITIONER
stating that the
FOOD
is free of a Shigella spp. infection based on
Not earlier than 48 hours after discontinuance of
antibiotics, and
26
27
PERSON IN CHARGE
(b)
(2)
At least 24 hours apart;
The FOOD EMPLOYEE was EXCLUDED or RESTRICTED after
28
symptoms of vomiting or diarrhea resolved, and more
29
than 7 calendar days have passed since the
30
EMPLOYEE
became
41
ASYMPTOMATIC;
or
FOOD
1
(3)
The
FOOD EMPLOYEE
was
EXCLUDED
or
04.05.11
and
RESTRICTED
2
did not develop symptoms and more than 7 calendar
3
days have passed since the
4
diagnosed.
(F)
Reinstate a
was
FOOD EMPLOYEE
5
EHEC or STEC
6
diagnosis –
RESTRICTED as specified under Subparagraphs 2-201. 12(A)(2)
7
removing
or (F)(1) or who was RESTRICTED under Subparagraph 2-201.12
8
exclusion or
(F)(2) if the
9
restriction
the REGULATORY AUTHORITY and one of the following conditions
10
is met:
11
(1)
The
FOOD EMPLOYEE
who was
PERSON IN CHARGE
EXCLUDED
or
EXCLUDED
or
obtains APPROVAL from
RESTRICTED FOOD EMPLOYEE
provides
12
to the PERSON IN CHARGE written medical documentation
13
from a
14
EMPLOYEE
15
ENTEROHEMORRHAGIC
16
ESCHERICHIA
17
consecutive negative stool specimen cultures that are
18
taken:
19
(a)
HEALTH PRACTITIONER
is
COLI
free
of
stating that the
an
or SHIGA
FOOD
infection
from
TOXIN-PRODUCING
based on test results that show 2
Not earlier than 48 hours after discontinuance of
20
antibiotics; and
21
(b)
22
(2)
The
At least 24 hours apart;
FOOD EMPLOYEE
was EXCLUDED or RESTRICTED after
23
symptoms of vomiting or diarrhea resolved and more
24
than 7 calendar days have passed since the
25
EMPLOYEE
26
(3)
became
ASYMPTOMATIC;
FOOD
or
The FOOD EMPLOYEE was EXCLUDED or
RESTRICTED
and
27
did not develop symptoms and more than 7 days have
28
passed since the FOOD EMPLOYEE was diagnosed.
29
sore throat with
(G)
Reinstate a
30
fever-
RESTRICTED
as
FOOD EMPLOYEE
specified under
42
who was
EXCLUDED
Subparagraphs
or
1
removing
04.05.11
2-201.12(G)(1) or (2) if the FOOD EMPLOYEE provides to the
2
exclusion
PERSON IN CHARGE
3
or restriction
HEALTH PRACTITIONER stating that the FOOD EMPLOYEE meets one
written medical documentation from a
4
of the following conditions:
5
(1)
6
Has received antibiotic therapy for Streptococcus
pyogenes infection for more than 24 hours;
7
(2)
8
Has at least one negative throat specimen culture for
Streptococcus pyogenes infection; or
9
(3)
10
Is otherwise determined by a
HEALTH PRACTITIONER
to
be free of a Streptococcus pyogenes infection.
11
Uncovered
(H)
Reinstate a
12
infected
specified under ¶ 2-201.12(H) if the skin, infected wound
13
wound or
cut, or pustular boil is properly covered with one of the
14
pustular
following:
15
boil – removing
(1)
16
restriction
FOOD EMPLOYEE
who was
RESTRICTED
as
An impermeable cover such as a finger cot or
stall and a single-use glove over the impermeable cover
17
if the infected wound or pustular boil is on the hand,
18
finger, or wrist;
19
(2)
20
An impermeable cover on the arm if the infected
wound or pustular boil is on the arm; or
21
(3)
22
A dry, durable, tight-fitting bandage if the infected
wound or pustular boil is on another part of the body.
23
exposure to
(I)
Reinstate a
24
foodborne
specified under ¶ 2-201.12(I) and was exposed to one of
25
pathogen
the following pathogens as specified under Subparagraph
26
and works in
2-201.11(A)(4) or (5):
27
food establishment
28
serving HSP – removing
29
restriction
FOOD EMPLOYEE
30
43
who was
RESTRICTED
as
1
Norovirus
(1)
2
04.05.11
Norovirus and one of the following conditions is met:
(a)
More than 48 hours have passed since the last
3
day the FOOD EMPLOYEE was potentially exposed;
4
or
5
(b)
More than 48 hours have passed since the FOOD
6
EMPLOYEE’S
7
ASYMPTOMATIC.
8
Shigella spp., EHEC,
9
or STEC
(2)
household
ESCHERICHIA
10
conditions is met:
11
(a)
the last day the
13
exposed; or
(b)
COLI
and one of the following
More than 3 calendar days have passed since
12
FOOD EMPLOYEE
was potentially
More than 3 calendar days have passed since
the FOOD EMPLOYEE’S household contact became
15
16
17
became
Shigella spp. or ENTEROHEMORRHAGIC or SHIGA TOXINPRODUCING
14
contact
ASYMPTOMATIC.
S. Typhi
(3)
18
S. Typhi and one of the following conditions is met:
(a)
More than 14 calendar days have passed since
19
the last day the
20
exposed; or
21
(b)
FOOD EMPLOYEE
was potentially
More than 14 calendar days have passed since
22
the FOOD EMPLOYEE’S household contact became
23
ASYMPTOMATIC.
24
hepatitis A
(4)
Hepatitis A virus and one of the following conditions is
25
met:
26
(a)
The
FOOD EMPLOYEE
is immune to hepatitis A
27
virus infection because of a prior illness from
28
hepatitis A;
29
30
(b)
The
FOOD EMPLOYEE
is immune to hepatitis A
virus infection because of vaccination against
44
04.05.11
1
hepatitis A;
2
(c)
3
The
FOOD EMPLOYEE
is immune to hepatitis A
virus infection because of IgG administration;
4
(d)
More than 30 calendar days have passed since
5
the last day the
6
exposed;
7
(e)
FOOD EMPLOYEE
was potentially
More than 30 calendar days have passed since
8
the FOOD EMPLOYEE’S household contact became
9
jaundiced; or
10
(f)
The FOOD EMPLOYEE does not use an alternative
11
procedure that allows bare hand contact with
12
READY-TO-EAT FOOD
13
the
14
Subparagraphs (I)(4)(d) and (e) of this section,
15
and the
16
training about:
17
(i)
potential
until at least 30 days after
exposure,
FOOD EMPLOYEE
as
specified
in
receives additional
Hepatitis A symptoms and preventing the
18
transmission of infection,
19
(ii)
Proper handwashing procedures, and
20
(iii)
Protecting
READY-TO-EAT
FOOD
from
21
contamination introduced by bare hand
22
contact.
23
2-3
24
PERSONAL CLEANLINESS
Subparts
25
2-301
Hands and Arms
26
2-302
Fingernails
27
2-303
Jewelry
28
2-304
Outer Clothing
2-301.11
Clean Condition.*
29
30
Hands and
45
1
Arms
FOOD
EMPLOYEES shall
2
arms clean.
3
2-301.12
4
(A)
04.05.11
keep their hands and exposed portions of their
Cleaning Procedure.*
Except as specified in ¶ (D) of this section,
FOOD EMPLOYEES
5
shall clean their hands and exposed portions of their arms,
6
including surrogate prosthetic devices for hands or arms for at
7
least 20 seconds, using a cleaning compound
8
HANDWASHING SINK
9
202.12 and Subpart 6-301.
10
(B)
in a
that is equipped as specified under § 5-
FOOD EMPLOYEES shall use the following cleaning procedure in
11
the order stated to clean their hands and exposed portions of
12
their arms, including surrogate prosthetic devices for hands
13
and arms.
14
(1)
Rinse under clean, running warm water;
15
(2)
Apply an amount of cleaning compound recommended
16
17
by the cleaning compound manufacturer;
(3)
Rub together vigorously for at least 10 to 15 seconds
18
while:
19
(a)
Paying particular attention to removing soil from
20
underneath the fingernails during the cleaning
21
procedure, and
22
(b)
Creating friction on the surfaces of the hands
23
and arms or surrogate prosthetic devices for
24
hands and arms, finger tips, and areas between
25
the fingers.
26
(4)
27
28
Thoroughly rinse under clean, running warm water;
and
(5)
Immediately follow the cleaning procedure with
29
thorough drying using a method as specified under
30
§ 6-301.12.
46
1
(C)
04.05.11
TO avoid recontaminating their hands or surrogate prosthetic
2
devices, FOOD EMPLOYEES may use disposable paper towels or
3
similar clean barriers when touching surfaces such as
4
manually operated faucet handles on a
5
the handle of a restroom door.
6
(D)
If
APPROVED
HANDWASHING SINK
or
and capable of removing the types of soils
7
encountered in the
8
handwashing facility may be used by FOOD EMPLOYEES to clean
9
their hands or surrogate prosthetic devices.
FOOD
operations involved, an automatic
10
2-301.13.
11
Reserved.
12
2-301.14
13
FOOD EMPLOYEES shall clean their hands and exposed portions of their
14
arms as specified under §2-301.12 immediately before engaging in
15
FOOD
16
EQUIPMENT and UTENSILS, and unwrapped SINGLE-SERVICE and SINGLE-
17
USE ARTICLES
18
(A)
19
Special Handwash Procedures.*
When to Wash.*
preparation including working with exposed
FOOD,
clean
and:
After touching bare human body parts other than clean hands
and clean, exposed portions of arms;
20
(B)
After using the toilet room;
21
(C)
After caring for or handling SERVICE ANIMALS or aquatic animals
22
23
as specified in ¶ 2-403.11(B);
(D)
Except as specified in ¶ 2-401.11(B), after coughing, sneezing,
24
using a handkerchief or disposable tissue, using tobacco,
25
eating, or drinking;
26
(E)
After handling soiled EQUIPMENT or UTENSILS;
27
(F)
During FOOD preparation, as often as necessary to remove soil
28
and contamination and to prevent cross contamination when
29
changing tasks;
30
(G)
When switching between working with raw FOOD and working
47
04.05.11
1
with READY-TO-EAT FOOD;
2
(H)
Before donning gloves for working with FOOD; and
3
(I)
After engaging in other activities that contaminate the hands.
4
2-301.15
5
FOOD
6
APPROVED
7
hands in a sink used for
8
service sink or a curbed cleaning facility used for the disposal of mop
9
water and similar liquid waste.
Where to Wash.
EMPLOYEES
10
2-301.16
11
(A)
shall clean their hands in a
HANDWASHING SINK
or
automatic handwashing facility and shall not clean their
FOOD
preparation or
WAREWASHING,
or in a
Hand Antiseptics.
A hand antiseptic used as a topical application, a hand
12
antiseptic solution used as a hand dip, or a hand antiseptic
13
soap shall:
14
(1)
15
Comply with one of the following:
(a)
Be an
APPROVED
drug that is listed in the FDA
16
publication Approved Drug Products with
17
Therapeutic Equivalence Evaluations as an
18
APPROVED
19
effectiveness; or
20
(b)
drug
based
on
safety
and
Have active antimicrobial ingredients that are
21
listed in the FDA monograph for OTC Health-
22
Care Antiseptic Drug Products as an antiseptic
23
handwash, and
24
25
(2)
Comply with one of the following:
(a)
Have components that are exempted from the
26
requirement of being listed in federal
27
ADDITIVE
28
170.39 - Threshold of regulation for substances
29
used in food-contact articles; or
30
(b)
regulations as specified in 21 CFR
Comply with and be listed in:
48
FOOD
1
04.05.11
21 CFR 178 - Indirect Food Additives:
(i)
2
Adjuvants,
3
Sanitizers as regulated for use as a FOOD
4
ADDITIVE
5
(ii)
Production
Aids,
and
with conditions of safe use, or
21 CFR 182 - Substances Generally
6
Recognized as Safe, 21 CFR 184 - Direct
7
Food Substances Affirmed as Generally
8
Recognized as Safe, or 21 CFR 186 -
9
Indirect Food Substances Affirmed as
10
Generally Recognized as Safe for use in
11
contact with food, and;
12
(3)
Be applied only to hands that are cleaned as specified
13
under § 2-301.12.
14
(B)
If a hand antiseptic or a hand antiseptic solution used as a
15
hand dip does not meet the criteria specified under
16
Subparagraph (A)(2) of this section, use shall be:
17
(1)
Followed by thorough hand rinsing in clean water
18
before hand contact with FOOD or by the use of gloves;
19
or
20
(2)
Limited to situations that involve no direct contact
21
with
22
(C)
FOOD
by the bare hands.
A hand antiseptic solution used as a hand dip shall be
23
maintained clean and at a strength equivalent to at least 100
24
MG/L
25
26
Fingernails
chlorine.
2-302.11
(A)
FOOD
Maintenance.
EMPLOYEES
shall keep their fingernails trimmed, filed,
27
and maintained so the edges and surfaces are cleanable and
28
not rough.
29
30
(B)
Unless wearing intact gloves in good repair, a FOOD EMPLOYEE
shall not wear fingernail polish or artificial fingernails when
49
04.05.11
1
2
working with exposed FOOD.
Jewelry
2-303.11
Prohibition.
3
Except for a plain ring such as a wedding band, while preparing FOOD,
4
FOOD EMPLOYEES shall
5
jewelry on their arms and hands.
6
Outer Clothing
2-304.11
Clean Condition.
7
FOOD
8
contamination of
9
SERVICE
10
2-4
11
not wear jewelry including medical information
shall wear clean outer clothing to prevent
EMPLOYEES
FOOD, EQUIPMENT, UTENSILS, LINENS,
and
SINGLE-
and SINGLE-USE ARTICLES.
HYGIENIC PRACTICES
Subparts
12
2-401
Food Contamination Prevention
13
2-402
Hair Restraints
14
2-403
Animals
Eating, Drinking, or Using Tobacco.*
15
16
Food
2-401.11
17
Contamination
(A)
18
Prevention
Except as specified in ¶ (B) of this section, an
EMPLOYEE
shall eat, drink, or use any form of tobacco
19
only in designated areas where the contamination of exposed
20
FOOD;
21
SINGLE-SERVICE
22
needing protection can not result.
23
(B)
clean
EQUIPMENT, UTENSILS,
and
and
LINENS;
SINGLE-USE ARTICLES;
unwrapped
or other items
A FOOD EMPLOYEE may drink from a closed BEVERAGE container
24
if the container is handled to prevent contamination of:
25
(1)
The EMPLOYEE'S hands;
26
(2)
The container; and
27
(3)
Exposed FOOD; clean EQUIPMENT, UTENSILS, and LINENS;
28
and
29
ARTICLES.
30
2-401.12
unwrapped
SINGLE-SERVICE
and
SINGLE-USE
Discharges from the Eyes, Nose, and Mouth.*
50
04.05.11
experiencing persistent sneezing, coughing, or a
1
FOOD
2
runny nose that causes discharges from the eyes, nose, or mouth
3
shall not work withexposed
4
LINENS;
EMPLOYEES
FOOD;
clean
or unwrapped SINGLE-SERVICE or
5
Hair
2-402.11
6
Restraints
(A)
EQUIPMENT, UTENSILS,
and
SINGLE-USE ARTICLES.
Effectiveness.
Except as provided in ¶ (B) of this section,
FOOD EMPLOYEES
7
shall wear hair restraints such as hats, hair coverings or nets,
8
beard restraints, and clothing that covers body hair, that are
9
designed and worn to effectively keep their hair from
10
contacting exposed
11
LINENS;
12
ARTICLES.
13
(B)
FOOD;
and unwrapped
clean
EQUIPMENT, UTENSILS,
SINGLE-SERVICE
This section does not apply to
and
and
SINGLE-USE
FOOD EMPLOYEES
such as
14
counter staff who only serve
15
PACKAGED FOODS,
16
minimal RISK of contaminating exposed FOOD; clean EQUIPMENT,
17
UTENSILS,
18
SINGLE-USE ARTICLES.
19
20
Animals
2-403.11
(A)
and
BEVERAGES
and wrapped or
hostesses, and wait staff if they present a
LINENS;
and unwrapped
SINGLE-SERVICE
and
Handling Prohibition.*
Except as specified in ¶ (B) of this section,
FOOD EMPLOYEES
21
shall not care for or handle animals that may be present such
22
as patrol dogs,
23
specified in Subparagraphs 6-501.115(B)(2)-(5).
24
(B)
FOOD
SERVICE ANIMALS,
EMPLOYEES
or pets that are allowed as
with SERVICE ANIMALS may handle or care for
25
their SERVICE ANIMALS and FOOD EMPLOYEES may handle or care
26
for FISH in aquariums or MOLLUSCAN SHELLFISH or crustacea in
27
display tanks if they wash their hands as specified under
28
§ 2-301.12 and ¶ 2-301.14(C).
51
04.05.11
1
Chapter
2
3
3
Parts
Food
4
3-1
CHARACTERISTICS
5
3-2
SOURCES, SPECIFICATIONS,
6
AND ORIGINAL CONTAINERS
AND
RECORDS
7
3-3
PROTECTION FROM CONTAMINATION AFTER RECEIVING
8
3-4
DESTRUCTION OF ORGANISMS OF PUBLIC HEALTH CONCERN
9
3-5
LIMITATION OF GROWTH OF ORGANISMS OF PUBLIC HEALTH
10
CONCERN
11
3-6
FOOD IDENTITY, PRESENTATION, AND ON-PREMISES LABELING
12
3-7
CONTAMINATED FOOD
13
3-8
SPECIAL
14
REQUIREMENTS
FOR
HIGHLY
SUSCEPTIBLE
POPULATIONS
15
16
3-1
CHARACTERISTICS
Subparts
17
18
3-101
Condition
3-101.11
Safe, Unadulterated, and Honestly Presented
19
20
Condition
21
FOOD shall be safe, unADULTERATED, and, as specified under
22
§ 3-601.12, honestly presented.
23
24
25
3-2
SOURCES, SPECIFICATIONS, AND ORIGINAL CONTAINERS AND
RECORDS
Subparts
26
3-201
Sources
27
3-202
Specifications for Receiving
28
3-203
Original Containers and Records
52
04.05.11
1
2
3
Sources
3-201.11
(A)
(B)
6
7
FOOD shall be obtained from sources that comply with
LAW .
4
5
Compliance with Food Law.*
FOOD prepared in a private home shall not be used or
offered for human consumption in a
(C)
PACKAGED
FOOD
FOOD ESTABLISHMENT.
shall be labeled as specified in
8
including
9
Labeling, Marking Devices, and Containers, and 9 CFR
10
381 Subpart N Labeling and Containers, and as specified
11
under §§ 3-202.17 and 3-202.18.
12
(D)
21 CFR 101 FOOD
Fish, other than
Labeling,
MOLLUSCAN SHELLFISH,
9
LAW ,
CFR 317
that are intended for
13
consumption in their raw form and allowed as specified in
14
Subparagraph 3-401.11(C)(1) may be offered for sale or
15
service if they are obtained from a supplier that freezes the
16
FISH as specified under
§ 3-402.11; or frozen on the
PREMISES
17
as specified under § 3-402.11 and records are retained as
18
specified under § 3-402.12.
19
(E)
W HOLE-MUSCLE,
20
consumption
21
CONSUMER
22
be:
23
(1)
INTACT BEEF
in
advisory
an
as
Obtained from a
steaks that are intended for
undercooked
form
without
a
specified in ¶ 3-401.11(C) shall
FOOD PROCESSING PLANT
that, upon
24
request by the purchaser, packages the steaks and
25
labels them, to indicate that
26
definition of
27
(2)
the steaks meet the
WHOLE-MUSCLE, INTACT BEEF,
Deemed acceptable by the
or
REGULATORY AUTHORITY
28
based on other evidence, such as written buyer
29
specifications or invoices, that indicates that the
30
steaks meet the definition of
53
WHOLE-MUSCLE, INTACT
1
BEEF,
2
(3)
3
04.05.11
and
If individually cut in a
(a)
Cut from
FOOD ESTABLISHMENT:
WHOLE-MUSCLE INTACT BEEF
4
labeled by a
5
specified
6
section
7
Subparagraph (E)(2) of this section.
in
FOOD
PROCESSING
Subparagraph
or
identified
PLANT
as
specified
(b)
Prepared so they remain intact, and
9
(c)
If
for undercooking in a
10
ESTABLISHMENT,
11
Subparagraph (E)(1)
12
identified
13
section.
14
(F)
MEAT and
POULTRY
as
labeled
specified
that is not a
as
of
as
(E)(1) of this
8
PACKAGED
that is
FOOD
specified
this
in
in
section or
in (E)(2)
of
READY-TO-EAT FOOD
this
and is
15
in a
16
offered for consumption, shall be labeled to include safe
17
handling instructions as specified in
18
317.2(l) and 9 CFR 381.125(b).
19
(G)
PACKAGED
form when it is offered for sale or otherwise
LAW ,
including 9 CFR
EGGS that have not been specifically treated to destroy
20
all viable Salmonellae shall be labeled to include safe
21
handling instructions as specified in
22
CFR 101.17(h).
LAW ,
including 21
23
3-201.12
24
FOOD in a
25
a
26
agency that has jurisdiction over the plant.
27
3-201.13
28
Fluid milk and milk products shall be obtained from sources
29
that comply with
30
3-201.14
Food in a Hermetically Sealed Container.*
HERMETICALLY SEALED CONTAINER
FOOD PROCESSING PLANT
shall be obtained from
that is regulated by the
FOOD
regulatory
Fluid Milk and Milk Products.*
GRADE A STANDARDS
Fish.*
54
as specified in
LAW .
1
(A)
04.05.11
FISH that are received for sale or service shall be:
2
(1)
Commercially and legally caught or harvested; or
3
(2)
APPROVED for sale or service.
4
(B)
5
MOLLUSCAN
that are recreationally caught shall
SHELLFISH
not be received for sale or service.
6
3-201.15
7
(A)
Molluscan Shellfish.*
MOLLUSCAN
SHELLFISH
shall be obtained from sources
8
according to
9
U.S. Department of Health and Human Services, Public
10
Health Service, Food and Drug Administration, National
11
Shellfish Sanitation Program Guide for the Control of
12
Molluscan Shellfish.
13
(B)
MOLLUSCAN
LAW
and the requirements specified in the
SHELLFISH
received in interstate commerce shall
be from sources that are listed in the Interstate Certified
14
15
Shellfish Shippers List.
16
3-201.16
17
(A)
Wild Mushrooms.*
Except
as specified in ¶ (B) of this section, mushroom
18
species picked in the wild shall be obtained from sources
19
where
20
found to be safe by an
21
expert.
22
23
(B)
each
mushroom is individually inspected and
APPROVED
mushroom identification
This section does not apply to:
(1)
Cultivated wild mushroom species that are grown,
24
harvested, and processed in an operation that is
25
regulated by the
26
jurisdiction over the operation; or
27
(2)
FOOD
regulatory agency that has
Wild mushroom species if they are in packaged
28
form and are the product of a
29
PLANT
30
agency that has jurisdiction over the plant.
that is regulated by the
55
FOOD PROCESSING
FOOD
regulatory
04.05.11
1
3-201.17
2
(A)
If
Game Animals.*
GAME ANIMALS
3
shall be:
4
(1)
5
are received
Commercially raised for
(a)
for sale or service they
Raised, slaughtered, and processed under a
6
voluntary inspection
7
conducted
8
health jurisdiction, or
9
(b)
and:
FOOD
by
Under a
program
that
is
the agency that has animal
routine
inspection
program
10
conducted by a regulatory agency other than
11
the
12
jurisdiction, and
13
(c)
agency
Raised,
that
has
slaughtered,
14
according to:
15
(i)
LAWS governing
animal
and
MEAT
and
health
processed
POULTRY
as
16
determined by the agency that has
17
animal health
18
agency that conducts the inspection
19
program, and
20
(ii)
jurisdiction
and
the
Requirements which are developed by
21
the agency that has animal health
22
jurisdiction
23
conducts the inspection program with
24
consideration of
25
need for antemortem and postmortem
26
examination
27
veterinarian or veterinarian’s designee;
28
(2)
and
by
the
agency
that
factors such as the
an
APPROVED
Under a voluntary inspection program administered
29
by the USDA for
30
animals (reindeer,
56
game animals such as exotic
elk,
deer,
antelope,
water
buffalo,
2
APPROVED”
3
animals; voluntary inspection or rabbits that are
4
“inspected and certified” in accordance with 9 CFR
5
354
6
products thereof;
7
(3)
or
bison)
that
are
04.05.11
“inspected and
1
in accordance with 9 CFR 352 Exotic
voluntary inspection
As allowed by
8
live-caught:
9
(a)
Under
of rabbits and edible
LAW ,
for wild
a
routine
GAME ANIMALS
inspection
that are
program
10
conducted by a regulatory agency such as
11
the
12
jurisdiction, and
13
(b)
14
agency
that
has
animal
health
Slaughtered and processed according to:
(i)
LAWS governing
MEAT
and
POULTRY
as
15
determined by the agency that has
16
animal
17
agency that conducts the inspection
18
program, and
19
(ii)
health jurisdiction and
the
Requirements which are developed by
20
the agency that has animal health
21
jurisdiction
22
conducts the inspection program with
23
consideration of
24
need for antemortem and postmortem
25
examination
26
veterinarian or veterinarian’s designee;
27
or
28
(4)
As
allowed
by
LAW ,
29
ANIMALS
30
ensures the animals:
and the
by
agency that
factors
an
such as the
APPROVED
for field-dressed wild
GAME
under a routine inspection program that
57
1
04.05.11
Receive a postmortem examination by an
(a)
2
APPROVED
3
designee, or
4
(b)
veterinarian
or
veterinarian's
Are field-dressed and transported according
5
to
6
that has animal health jurisdiction and
7
agency
8
program, and
9
(c)
requirements specified by
that
conducts
Are processed according to
10
MEAT
the agency
the
the
inspection
LAWS
governing
and POULTRY as determined by the agency
11
that has animal health jurisdiction and the
12
agency that conducts the inspection program.
13
(B)
A
GAME ANIMAL
shall not be received for sale or service if
14
it is a species of wildlife that is listed in 50 CFR 17
15
Endangered and threatened wildlife and plants.
16
Specifications
3-202.11
17
for Receiving
(A)
Temperature.*
Except as specified in ¶ (B) of this section, refrigerated,
18
POTENTIALLY HAZARDOUS FOOD (TIME/TEMPERATURE CONTROL FOR
19
SAFETY FOOD)
20
below when received.
21
(B)
shall be at a temperature of 5oC (41oF) or
If a temperature other than 5°C (41°F) for a
POTENTIALLY
22
HAZARDOUS FOOD (TIME/TEMPERATURE CONTROL FOR SAFETY FOOD)
23
is specified in
24
governing milk and
25
received at the specified temperature.
26
(C)
Raw
EGGS
LAW
governing its distribution, such as
MOLLUSCAN SHELLFISH,
the
LAWS
FOOD may
be
shall be received in refrigerated equipment that
27
maintains an ambient air temperature of 7oC (45oF) or
28
less.
29
30
(D)
POTENTIALLY
HAZARDOUS FOOD (TIME/TEMPERATURE CONTROL FOR
SAFETY FOOD)
that is cooked to a temperature and for a
58
1
04.05.11
time specified under §§ 3-401.11 - 3-401.13 and received
2
hot shall be at a temperature of 57oC (135oF) or above.
3
4
(E)
5
6
A
FOOD
that is labeled frozen and shipped frozen by a
FOOD PROCESSING PLANT
(F)
shall be received frozen.
Upon receipt, POTENTIALLY HAZARDOUS FOOD (TIME/TEMPERATURE
7
CONTROL FOR SAFETY FOOD)
8
previous temperature abuse.
9
3-202.12
shall be free of evidence of
Additives.*
10
FOOD shall not contain unAPPROVED
11
that exceed amounts specified in 21 CFR 170-180 relating to
12
ADDITIVES,
13
substances that exceed amounts specified in 21 CFR 181-186,
14
substances that exceed amounts specified in 9 CFR Subpart C
15
Section 424.21(b). Food ingredients and sources of radiation, or
16
pesticide residues that exceed provisions specified in 40 CFR 180
17
Tolerances for pesticides chemicals in food, and exceptions.
18
3-202.13
19
EGGS
20
exceed the restricted
21
B as specified in United States Standards, Grades, and Weight
22
Classes for Shell Eggs, AMS 56.200 et seq., administered by
23
the Agricultural Marketing Service of USDA.
24
3-202.14
25
(A)
EGG
26
(B)
Fluid and dry milk and milk products shall:
FOOD ADDITIVES
generally recognized as safe or
or
ADDITIVES
FOOD
prior sanctioned
Eggs.*
shall
be
received
EGG
clean
and sound and shall not
tolerances for U.S. Consumer Grade
Eggs and Milk Products, Pasteurized.*
PRODUCTS
shall be obtained pasteurized.
27
(1)
Be obtained pasteurized; and
28
(2)
Comply with GRADE A STANDARDS as specified in
LAW.
29
30
(C)
Frozen milk
products, such
59
as
ice
cream,
shall
be
1
obtained
2
Frozen desserts.
3
(D)
pasteurized as
specified
in
04.05.11
21 CFR 135 –
Cheese shall be obtained pasteurized unless alternative
4
procedures to pasteurization are specified in the CFR,
5
such
6
products, for curing certain cheese varieties.
as
21 CFR 133 - Cheeses and
related cheese
7
3-202.15
8
FOOD packages shall be in good condition and protect the
9
integrity of the contents so that the
Package Integrity.*
FOOD
10
ADULTERATION
or potential contaminants.
11
3-202.16
Ice.*
12
Ice for use as a
13
DRINKING WATER.
14
3-202.17
15
Identification.
16
(A)
Raw
FOOD
is not exposed to
or a cooling medium shall be made from
Shucked
Shellfish,
SHUCKED SHELLFISH
Packaging
and
shall be obtained in nonreturnable
17
packages which bear a legible label that identifies the:
18
(1)
Name, address, and
19
shucker-packer
20
SHELLFISH;
21
(2)
The
or
“sell by” or
packages
with
23
(one-half
gallon)
24
packages
with
25
gallon) or more.
(B)
repacker
of
the
of the
MOLLUSCAN
and
22
26
CERTIFICATION NUMBER
A package of raw
“best if used by” date for
a capacity
or
the
of less than 1.89 L
date
shucked
for
a capacity of 1.89 L (one-half
SHUCKED SHELLFISH
that does not bear
27
a label or which bears a label which does not contain all
28
the information as specified under ¶ (A) of this section
29
shall be subject to a hold order, as allowed by
30
seizure and destruction in accordance with 21 CFR
60
LAW ,
or
1
04.05.11
Subpart D - Specific Administrative Decisions Regarding
2
Interstate Shipments, Section 1240.60(d) Molluscan shellfish.
3
4
3-202.18
5
(A)
Shellstock Identification.*
SHELLSTOCK shall be obtained in containers bearing
6
legible
source
identification
7
affixed by the harvester or
8
or reships the
9
Shellfish Sanitation Program
tags or labels that are
DEALER
SHELLSTOCK,
that depurates, ships,
as specified in the National
Guide for the Control of
10
Molluscan Shellfish, and that list:
11
(1)
Except as specified under ¶ (C) of this section, on
12
the
13
information in the following order:
14
(a)
15
harvester's
tag
or
label,
the
following
The harvester's identification number that is
assigned by the
SHELLFISH CONTROL AUTHORITY,
16
(b)
The date of harvesting,
17
(c)
The
most
precise
identification
of
the
18
harvest location or aquaculture site that is
19
practicable based on the system of harvest
20
area
21
SHELLFISH CONTROL AUTHORITY
22
the abbreviation of the name of the state or
23
country in which the shellfish are harvested,
designations
that is in use by the
and including
24
(d)
The type and quantity of shellfish, and
25
(e)
The
following statement in bold, capitalized
26
type:
“This tag is required to be attached
27
until container is empty or retagged and
28
thereafter kept on file for 90 days;” and
29
30
(2)
Except as specified in ¶ (D) of this section, on
each
DEALER's
61
tag
or
label,
the
following
1
information in the following order:
2
(a)
The
DEALER's
04.05.11
name and address, and the
3
CERTIFICATION
4
SHELLFISH CONTROL AUTHORITY,
5
(b)
assigned
NUMBER
The original shipper's
by
the
CERTIFICATION NUMBER
6
including
7
the state or country in which the shellfish
8
are harvested,
9
(c)
the abbreviation of the name of
The same information as specified for a
10
harvester's
11
(A)(1)(b)-(d) of this section, and
12
(d)
tag
under
Subparagraphs
The following statement in bold, capitalized
13
type:
14
until container is empty and thereafter kept
15
on file for 90 days.”
16
(B)
A container of
“This tag is required to be attached
SHELLSTOCK
that does not bear a tag or
17
label or that bears a tag or label that does not contain
18
all the information
19
section shall be subject to a hold order, as allowed by
20
LAW ,
21
21 CFR
22
Regarding Interstate Shipments, Section 1240.60(d).
23
(C)
24
26
destruction
in
accordance with
Subpart D - Specific Administrative Decisions
DEALER's
DEALER's
(D)
and
of this
If a place is provided on the harvester's tag or label for
a
25
or seizure
as specified under ¶ (A)
If
the
name, address, and
CERTIFICATION NUMBER,
the
information shall be listed first.
harvester's
tag
or
label
is
designed
to
27
accommodate
28
under Subparagraphs (A)(2)(a) and (b) of this section,
29
individual
30
3-202.19
each
DEALER
DEALER's
tags or labels need not be provided.
Shellstock, Condition.
62
identification as specified
1
When received by a
FOOD ESTABLISHMENT, SHELLSTOCK
2
reasonably free
3
broken shells. Dead shellfish or
4
shells shall be discarded.
5
3-202.110
of
04.05.11
shall be
mud, dead shellfish, and shellfish with
with badly broken
SHELLSTOCK
Juice Treated.
6
Commercially
Pre-PACKAGED
7
Processed
(A)
JUICE
shall:
Be obtained from a processor with a HACCP system as
8
specified in 21 CFR Part 120 Hazard Analysis
9
Critical Control (HACCP) Systems; and
10
(B)
and
Be obtained pasteurized or otherwise treated to attain a
11
5-log reduction of the most resistant microorganism of
12
public health significance as specified in 21 CFR Part
13
120.24 Process Controls.
14
3-203.11
Molluscan Shellfish, Original Container.
15
(A)
as
16
Except
specified
MOLLUSCAN SHELLFISH
in
¶¶ (B) - (D)
of this section,
shall not be removed from the container
17
in which they are received other than immediately before
18
sale or preparation for service.
19
Original
20
Containers and
the container in which they are received, displayed on
21
Records
drained ice, or held in a display
(B)
For display purposes,
SHELLSTOCK
22
quantity specified by a
23
the display
24
CONSUMER
25
(1)
The
CONSUMER
may be removed from
container, and
may be removed from
or display container and provided to the
if:
source of
the
SHELLSTOCK
on
display
26
identified
27
recorded as specified under § 3-203.12; and
28
29
30
(2)
(C)
The
SHUCKED
a
as
SHELLSTOCK
SHELLFISH
specified
under § 3-202.18
is
and
are protected from contamination.
may be removed from the container in
which they were received and held in a display container
63
04.05.11
from which individual servings are dispensed upon a
1
2
CONSUMER'S
3
(1)
request if:
The labeling information for the shellfish on display
4
as specified under
5
correlated to the date when, or dates during which,
6
the shellfish are sold or
7
8
(2)
(D)
9
§ 3-202.17 is retained and
The shellfish are protected from contamination.
SHUCKED
SHELLFISH
may be removed from the container in
which they were received and repacked in
10
service containers where allowed by
11
(1)
CONSUMER
self
if:
LAW
The labeling information for the shellfish is
on
12
each
13
under § 3-202.17 and ¶¶ 3-602.11(A) and (B)(1) -
14
(5);
15
(2)
The
CONSUMER
self service container as specified
labeling
information as
specified under
16
§ 3-202.17 is retained and correlated with the date
17
when,
18
sold or served;
19
(3)
or
dates during which, the shellfish are
The labeling information and dates specified under
20
Subparagraph
21
maintained for 90 days; and
22
(4)
23
3-203.12
24
(A)
(D)(2)
to the container in which the
27
until the container is empty.
30
are
Except as specified under Subparagraph (C) (2) of this
26
29
section
Shellstock, Maintaining Identification.*
section,
(B)
this
The shellfish are protected from contamination.
25
28
of
SHELLSTOCK
tags or labels shall remain attached
The date when the last
SHELLSTOCK
SHELLSTOCK
are received
from the container is
sold or served shall be recorded on the tag or label.
(C)
The identity of the source of
64
SHELLSTOCK
that are sold
04.05.11
1
or served shall be maintained by retaining
2
tags or labels for 90 calendar days from the date that
3
is recorded on the tag or label, as specified under ¶ B
4
of this section, by:
5
(1)
Using an
APPROVED
SHELLSTOCK
record keeping system that
6
keeps the tags or labels in chronological order
7
correlated to the date that is recorded on the tag
8
or label, as specified under ¶ B of this section;
9
and
10
(2)
If
SHELLSTOCK
11
container:
12
(a)
are removed from its tagged or labeled
Preserving source identification by using a
13
record keeping system as specified under
14
Subparagraph (C)(1) of this section, and
15
(b)
Ensuring that
SHELLSTOCK
from one tagged or
labeled container are not
16
COMMINGLED
from another container
with
17
SHELLSTOCK
18
different
19
harvest dates; or different growing areas as
20
identified on the tag or label before being
21
ordered by the
CERTIFICATION
NUMBERS;
with
different
CONSUMER.
22
23
24
3-3
PROTECTION FROM CONTAMINATION AFTER RECEIVING
Subparts
25
3-301
Preventing Contamination by Employees
26
3-302
Preventing Food and Ingredient Contamination
27
3-303
Preventing Contamination from Ice Used as a
28
Coolant
65
1
3-304
Preventing
2
Contamination
04.05.11
Equipment,
from
Utensils, and Linens
3
3-305
Preventing Contamination from the Premises
4
3-306
Preventing Contamination by Consumers
5
3-307
Preventing Contamination from Other Sources
Preventing Contamination from Hands.*
6
7
Preventing
3-301.11
8
Contamination
(A)
9
by Employees
10
FOOD
EMPLOYEES
shall wash their hands as specified
under § 2-301.12.
(B)
Except
when washing fruits and vegetables as specified
11
under § 3-302.15 or as specified in ¶ (D) of this section,
12
FOOD EMPLOYEES
13
FOOD
14
UTENSILS
15
gloves, or dispensing
16
(C)
FOOD
shall not contact exposed,
with their bare hands and shall use suitable
such as deli tissue, spatulas, tongs, single-use
EMPLOYEES
contact with exposed
18
form.S
(D)
FOOD
EMPLOYEES
EQUIPMENT.
shall minimize bare hand and arm
17
19
FOOD
may contact exposed,
21
hands if:
22
(1)
24
The
that is not in a
READY-TO-EAT
not serving a HIGHLY SUSCEPTIBLE POPULATION
20
23
READY-TO-EAT
READY-TO-EAT FOOD
PERMIT HOLDER
obtains prior
with their bare
APPROVAL
REGULATORY AUTHORITY;
(2)
Written procedures are maintained in the
25
ESTABLISHMENT
26
REGULATORY AUTHORITY
27
(a)
and
made
available
to the
For each bare hand contact procedure, a
listing
29
that are touched by bare hands,
(b)
FOOD
upon request that include:
28
30
from the
of the specific
READY-TO-EAT FOODS
Diagrams and other information showing that
66
04.05.11
located,
1
handwashing
2
equipped,
3
under §§ 5-203.11, 5-204.11, 5-205.11, 6-
4
301.11, 6-301.12,
and 6-301.14,
are in an
5
easily accessible
location
in
6
proximity to the work station where the bare
7
hand contact procedure is conducted;
8
(3)
9
A written
the
facilities,
and
installed,
maintained
as specified
and
close
health policy that details how
EMPLOYEE
FOOD ESTABLISHMENT
complies with §§ 2-201.11,
10
2-201.12, and 2-201.13 including:
11
(a)
Documentation
that
FOOD
EMPLOYEES
and
12
CONDITIONAL EMPLOYEES
13
are informed to report information about their
14
health
15
gastrointestinal symptoms and diseases that
16
are transmittable through
17
under ¶ 2-201.11(A),
18
(b)
and
acknowledge that they
activities
Documentation
that
as
they
FOOD
FOOD
relate
to
as specified
EMPLOYEES
and
19
CONDITIONAL
20
responsibilities as specified under ¶ 2-201.11(E)
21
and (F), and
22
(c)
EMPLOYEES
Documentation that the
acknowledge
their
PERSON IN CHARGE
23
acknowledges
24
specified under ¶¶ 2-201.11(B), (C) and (D),
25
and §§ 2-201.12 and 2-201.13;(4)
26
(4)
the
Documentation that
responsibilities
FOOD EMPLOYEES
27
that they have received training in:
28
(a)
29
30
The
RISKS of
EAT FOODS
(b)
as
acknowledge
contacting the specific
READY-TO-
with bare hands,
Proper handwashing as specified under § 267
04.05.11
1
301.12,
2
(c)
3
under § 2-301.14,
4
(d)
5
Where to wash their hands as specified
under § 2-301.15,
6
(e)
7
Proper fingernail maintenance as specified
under § 2-302.11,
8
(f)
9
Prohibition of jewelry as specified under § 2303.11, and
10
(g)
11
12
When to wash their hands as specified
Good hygienic practices as specified under
§§2-401.11 and 2-401.12;
(5)
Documentation that
hands
13
FOOD
14
cross contamination by FOOD
15
are washed before
preparation and as necessary to prevent
under
§§ 2-301.11,
EMPLOYEES
2 301.12,
as specified
2-301.14,
and
16
2-301.15 during all hours of operation when the
17
specific
18
(6)
READY-TO-EAT FOODS
are prepared;
Documentation that FOOD EMPLOYEES contacting
READY-
19
TO-EAT FOOD
20
the following control measures to provide additional
21
safeguards to
22
contact:
23
(a)
Double handwashing,
24
(b)
Nail brushes,
25
(c)
A hand antiseptic after handwashing as
26
with bare hands use two or more of
HAZARDS
associated with bare hand
specified under § 2-301.16,
68
1
(d)
04.05.11
Incentive programs such as paid sick leave
2
that assist or encourage
3
to work when they are ill, or
4
(e)
5
Other control measures
REGULATORY AUTHORITY;
6
(7)
FOOD EMPLOYEES
APPROVED
not
by the
and
Documentation that corrective action is taken when
7
Subparagraphs (D)(1) - (6) of this section are not
8
followed.
9
3-301.12
10
A
11
taste
12
Preventing Food
13
and Ingredient
14
Contamination
15
Preventing Contamination When Tasting.*
FOOD EMPLOYEE
FOOD
3-302.11
shall not use a
UTENSIL
that is to be sold or served.
Packaged and Unpackaged Food - Separation,
Packaging, and Segregation.*
(A)
FOOD shall be protected from cross contamination by:
(1)
16
Separating
raw
animal
during
FOODS
storage,
preparation, holding, and display from:
17
(a)
Raw
READY-TO-EAT FOOD
18
animal
19
MOLLUSCAN SHELLFISH,
20
EAT FOOD
21
and
22
23
more than once to
(b)
(2)
Cooked
FOOD
such as
such
including other raw
FISH
for sushi or
or other raw
READY-TO-
as fruits and vegetables,
READY-TO-EAT FOOD;
Except when combined as ingredients, separating
24
types of raw animal
25
as beef,
26
preparation, holding, and display by:
27
(a)
Using separate
28
(b)
Arranging each type of
FISH,
FOODS
from each other such
lamb, pork, and POULTRY during storage,
EQUIPMENT
for each type, or
FOOD
in
EQUIPMENT
29
so that cross contamination of one type with
30
another is prevented, and
69
1
(c)
Preparing each type of
2
04.05.11
at different
FOOD
times or in separate areas;
3
(3)
Cleaning
EQUIPMENT
and
4
under ¶ 4-602.11(A ) and
5
under § 4-703.11;
6
(4)
Except
as
specified
UTENSILS
as specified
as specified
SANITIZING
under
Subparagraph
3
7
-501.15(B)(2) and in ¶ (B) of this section, storing
8
the
9
wrappings;
10
(5)
11
FOOD
Cleaning
in packages, covered containers, or
HERMETICALLY SEALED CONTAINERS
of
FOOD of
visible soil before opening;
12
(6)
Protecting
containers that
FOOD
are received
13
packaged together
14
cuts when the case or overwrap is opened;
15
(7)
Storing damaged, spoiled, or recalled
16
held in the
17
§ 6-404.11; and
18
(8)
are
20
from
22
(B)
FOOD ESTABLISHMENT
Separating
19
21
in a case or overwrap from
fruits
washed
and
as
FOOD
being
as specified under
vegetables,
specified
before
they
under § 3-302.15
READY-TO-EAT FOOD.
Subparagraph (A)(4) of this section does not apply to:
(1)
Whole, uncut, raw fruits and vegetables and nuts
23
in the shell, that require peeling or hulling before
24
consumption;
25
(2)
PRIMAL
CUTS,
quarters, or sides of raw
26
slab bacon that are hung on clean,
27
or placed on clean,
28
(3)
Whole,
SANITIZED
uncut, processed
MEAT
SANITIZED
or
hooks
racks;
MEATS
such as country
29
hams, and smoked or cured sausages that are
30
placed on clean,
70
SANITIZED
racks;
1
(4)
FOOD
being
cooled
as
specified
2
Subparagraph 3-501.15(B)(2); or
3
(5)
4
3-302.12
04.05.11
under
SHELLSTOCK.
Food Storage Containers, Identified with Common
5
Name of Food.
6
Except for containers holding
7
unmistakably recognized such as dry pasta, working containers
8
holding
9
original packages for use in the
or
FOOD
FOOD
that can be readily and
ingredients that are removed from their
FOOD
FOOD ESTABLISHMENT,
such as
10
cooking oils, flour, herbs, potato flakes, salt, spices, and sugar
11
shall be identified with the common name of the
12
3-302.13
FOOD.
Pasteurized Eggs, Substitute for Raw Eggs for
13
Certain Recipes.*
14
Pasteurized
15
raw
16
hollandaise
17
eggnog,
18
not:
19
(A)
20
EGGS
EGGS
or
EGG PRODUCTS
in the preparation of
or
ice
Béarnaise
cream,
Cooked
and
as
shall
FOODS
be
substituted
for
such as Caesar salad,
sauce, mayonnaise, meringue,
EGG-fortified
specified
BEVERAGES
under
that are
Subparagraphs
3-401.11(A)(1) or (2); or
21
(B)
Included in ¶ 3-401.11(D).
22
3-302.14
23
(A)
Protection from Unapproved Additives.*
FOOD shall be protected from contamination that may
24
result from the addition of, as specified in § 3-202.12:
25
(1)
26
(2)
28
30
FOOD
or
COLOR ADDITIVES;
and
27
29
Unsafe or unAPPROVED
Unsafe or unapproved levels of
APPROVED FOOD
and
COLOR ADDITIVES.
(B)
A
FOOD EMPLOYEE
(1)
may not:
Apply sulfiting agents to fresh fruits and vegetables
71
intended for
2
considered to be a good source of vitamin B1; or
3
(2)
raw consumption or
Except for grapes, serve or sell
to
a
04.05.11
1
FOOD
specified
FOOD
4
under Subparagraph (B)(1) of this section that is
5
treated with sulfiting agents before receipt by the
6
FOOD
7
3-302.15
8
(A)
ESTABLISHMENT.
Washing Fruits and Vegetables.
Except as specified in ¶ (B) of this section and except
for whole, raw fruits and vegetables that are intended for
9
10
washing by the
11
and
12
remove
13
combined with other ingredients, cooked, served, or
14
offered for human consumption in
15
(B)
16
Fruits
before consumption, raw fruits
vegetables shall be thoroughly washed in water to
soil and other contaminants
and
vegetables
may
before
being cut,
READY-TO-EAT
be
washed
form.
by
using
chemicals as specified under § 7-204.12.
17
Preventing
18
Contamination
19
from Ice Used
20
as a Coolant
3-303.11
Ice Used as Exterior Coolant, Prohibited as
Ingredient.
After use as a medium for cooling the exterior surfaces of
such as melons or
21
BEVERAGES,
22
not be used as
23
3-303.12
24
25
CONSUMER
FISH, PACKAGED FOODS
or cooling coils and tubes of
FOOD
such as canned
EQUIPMENT,
ice shall
FOOD.
Storage or Display of Food in Contact with
Water or Ice.
(A)
PACKAGED
FOOD
shall not be stored in direct contact with
26
ice or water if the
27
because of the nature of its packaging, wrapping, or
28
container or its positioning in the ice or water.
29
30
(B)
FOOD
is subject to the entry of water
Except as specified in ¶¶ (C) and (D) of this section,
unPACKAGED
FOOD
72
shall not
be stored in direct contact
1
04.05.11
with undrained ice.
2
(C)
Whole, raw fruits or vegetables; cut, raw vegetables such
3
as celery or carrot sticks or cut potatoes; and tofu may
4
be immersed in ice or water.
5
(D)
Raw poultry and raw
FISH
that are received immersed in
6
ice in shipping containers may remain in that condition
7
while in storage awaiting preparation, display, service, or
8
sale.
Preventing
3-304.11
10
Contamination
FOOD shall only contact surfaces of:
11
from Equipment,
(A)
12
Utensils, and
under Part 4-6 of this Code and
13
Linens
under Part 4-7 of this Code; or
9
Food Contact with Equipment and Utensils.*
EQUIPMENT and
UTENSILS
14
(B)
SINGLE-SERVICE and
15
3-304.12
16
During
17
preparation and dispensing
18
(A)
pauses
in
as specified
SINGLE-USE ARTICLES.
FOOD
preparation or dispensing,
UTENSILS
20
the container;
shall be stored:
with their handles above the top of the
FOOD
CONTROL FOR SAFETY FOOD) with
23
of the
24
closed, such as bins of sugar, flour, or cinnamon;
(C)
and
In FOOD that is not POTENTIALLY HAZARDOUS ( TIME/TEMPERATURE
22
25
FOOD
Except as specified under ¶ (B) of this section, in the
FOOD
(B)
SANITIZED
In-Use Utensils, Between -Use Storage.
19
21
that are cleaned as specified
FOOD
their handles above the top
within containers or EQUIPMENT that can be
On a clean portion of the
FOOD
preparation table or
26
cooking
27
FOOD-CONTACT surface of the FOOD preparation table or cooking
28
EQUIPMENT
29
30
EQUIPMENT
only if the in-use
are cleaned and
UTENSIL
SANITIZED
and the
at a frequency
specified under §§ 4-602.11 and 4-702.11;
(D)
In
running
water
73
of
sufficient
velocity
to
flush
1
particulates to the drain, if used with moist
2
as ice cream or mashed potatoes;
3
(E)
In a clean, protected location if the
04.05.11
such
FOOD
UTENSILS,
such as
4
ice scoops, are used only with a
5
POTENTIALLY HAZARDOUS (TIME/TEMPERATURE CONTROL FOR SAFETY
6
FOOD);
7
(F)
FOOD
that is not
or
In a container of water if the water is maintained at a
8
temperature of at least 60oC (140oF) and the container is
9
cleaned at a frequency specified under Subparagraph 4-
10
602.11(D)(7).
11
3-304.13
12
LINENS and napkins shall not be used in contact with
13
unless they are used to line a container for the service of
14
FOODS
15
container is refilled for a new
16
3-304.14
17
(A)
Linens and Napkins, Use Limitation.
and the
LINENS
and napkins are replaced each time the
CONSUMER.
Wiping Cloths, Use Limitation.
Cloths in-use for wiping
FOOD
spills from
18
carry-out containers that occur as
19
shall be:
20
(1)
Maintained dry; and
21
(2)
Used for no other purpose.
22
(B)
surfaces shall be:
24
(1)
at
26
and
(2)
(C)
TABLEWARE
and
is being served
other
EQUIPMENT
Held between uses in a chemical sanitizer solution
25
28
FOOD
Cloths in-use for wiping counters and
23
27
FOOD
a concentration specified under § 4-501.114;
Laundered daily as specified under ¶ 4-802.11(D).
Cloths in-use for wiping surfaces in contact with raw
29
animal
30
other purposes.
FOODS
shall be kept separate from cloths used for
74
1
(D)
04.05.11
Dry wiping cloths and the chemical sanitizing solutions
2
specified in Subparagraph (B)(1) of this section in which
3
wet wiping cloths are held between uses shall be free
4
of
5
(E)
FOOD
debris and visible soil.
Containers of chemical sanitizing solutions specified in
6
Subparagraph (B)(1) of this section in which wet wiping
7
cloths are held between uses shall
8
floor and used in a manner that prevents contamination
9
of
10
11
be stored off the
FOOD, EQUIPMENT, UTENSILS, LINENS, SINGLE-SERVICE,
or
SINGLE-USE ARTICLES.
(F)
SINGLE-USE disposable sanitizer wipes shall be used in
12
accordance with EPA-approved manufacturer’s label use
13
instructions.
14
3-304.15
15
(A)
Gloves, Use Limitation.
If used,
SINGLE-USE
16
task
17
raw animal
18
discarded
19
interruptions occur in the operation.
20
(B)
such
gloves shall be used
as working with
FOOD,
used
when
READY-TO-EAT FOOD
for
no
other
damaged
or
soiled,
gloves
22
operations requiring cutting shall
23
contact only with
24
specified
25
PRIMAL CUT
(C)
or with
purpose,
or
and
when
Except as specified in ¶ (C) of this section, slash-resistant
21
26
for only one
that
are used
FOOD
to
protect
the
hands
during
be used in
direct
that is subsequently cooked as
under Part 3-4 such as frozen
of
FOOD
or a
MEAT.
Slash-resistant gloves may be used with READY-TO-EAT FOOD
27
that will not be subsequently cooked if the slash-resistant
28
gloves have a
29
surface; or if the slash-resistant gloves are covered with
30
a
SMOOTH,
SMOOTH,
durable, and nonabsorbent outer
durable, nonabsorbent glove, or a
75
SINGLE-USE
04.05.11
1
2
glove.
(D)
Cloth gloves shall not be used in direct contact with
3
FOOD
4
required under Part 3-4 such as frozen
5
CUT
6
3-304.16
7
8
unless
the
FOOD
is
subsequently
PRIMAL
MEAT.
of
Using Clean Tableware for Second Portions and
(A)
Except
for
container
refilling
a
CONSUMER’S
and the lip-contact area
of
11
container,
shall
12
including
13
to provide second portions or refills.
(B)
FOOD EMPLOYEES
the
SINGLE-SERVICE ARTICLES,
cup
or
UTENSIL
drinking cup or
not use
TABLEWARE,
soiled by the
CONSUMER,
Except as specified in ¶ (C) of this section, self-service
15
CONSUMERS
16
TABLEWARE,
17
additional
18
EQUIPMENT.
(C)
drinking
without contact between the pouring
10
19
or a
as
Refills.
9
14
FOOD
cooked
shall
not
including
FOOD
be
allowed
to
use
SINGLE-SERVICE ARTICLES,
from
the
display
and
soiled
to obtain
serving
Drinking cups and containers may be reused by self-
20
service
21
process as specified under ¶¶ 4-204.13(A), (B), and (D).
22
3-304.17
23
(A)
24
if
refilling
is
a
contamination-free
Refilling Returnables.
A take-home FOOD container returned to a FOOD ESTABLISHMENT
shall not be refilled at a
25
FOOD ESTABLISHMENT
with a
POTENTIALLY HAZARDOUS FOOD (TIME/TEMPERATURE CONTROL FOR
26
27
CONSUMERS
SAFETY FOOD).
(B)
Except as specified in ¶ (C), a take-home
28
refilled with
29
(TIME/TEMPERATURE
30
cleaned as specified under ¶ 4-603.17(B).
FOOD
76
that is not
FOOD
container
POTENTIALLY HAZARDOUS
CONTROL FOR SAFETY FOOD)
shall be
1
(C)
Personal
take-out
BEVERAGE
containers,
04.05.11
such as
2
thermally insulated bottles, nonspill coffee cups, and
3
promotional
4
or the
5
process as specified under ¶¶ 4-204.13(A), (B), and (D).
BEVERAGE
CONSUMER
glasses, may be refilled by EMPLOYEES
if refilling is a
contamination-free
6
Preventing
3-305.11
7
Contamination
(A)
8
from the
shall be protected from contamination by storing the FOOD:
9
Premises
(1)
In a clean, dry location;
(2)
Where it is not exposed to splash, dust, or other
10
Except as specified in ¶¶ (B) and (C) of this section, FOOD
11
contamination; and
12
13
Food Storage.
(3)
(B)
At least 15 cm (6 inches) above the floor.
FOOD in packages and working containers may be stored
14
less than 15 cm (6 inches) above the floor on case
15
handling
16
(C)
EQUIPMENT
Pressurized
lot
as specified under § 4-204.122.
BEVERAGE
containers,
cased
FOOD
in
17
waterproof containers such as bottles or cans, and
18
containers in plastic crates may be stored on a floor that
19
is clean and not exposed to floor moisture.
20
3-305.12
21
FOOD shall not be stored:
Food Storage, Prohibited Areas.
22
(A)
In locker rooms;
23
(B)
In toilet rooms;
24
(C)
In dressing rooms;
25
(D)
In garbage rooms;
26
(E)
In mechanical rooms;
27
(F)
Under
28
29
30
milk
sewer
lines
that
are not shielded to
intercept potential drips;
(G)
Under
leaking
water lines, including
leaking
automatic fire sprinkler heads, or under lines on
77
1
04.05.11
which water has condensed;
2
(H)
Under open stairwells; or
3
(I)
Under other sources of contamination.
4
3-305.13
Vended
Potentially
5
(Time/Temperature
6
Original Container
Hazardous
Food
Control for Safety Food),
7
POTENTIALLY HAZARDOUS FOOD (TIME/TEMPERATURE CONTROL FOR SAFETY
8
FOOD)
9
PACKAGE
dispensed through a
VENDING MACHINE
in which it was placed at the
shall be in the
or
FOOD ESTABLISHMENT
10
FOOD PROCESSING PLANT
at which it was prepared.
11
3-305.14
12
During preparation, unPACKAGED
13
environmental sources of contamination.
Food Preparation.
FOOD
shall be protected from
14
Preventing
3-306.11
15
Contamination
Except for nuts
16
by Consumers
vegetables that are intended for hulling, peeling, or washing by
Food Display.
in
the shell and
whole, raw
on display shall be
17
the
18
protected from contamination by the use of
19
service line, or salad bar
20
effective means.
21
3-306.12
22
(A)
CONSUMER
before consumption,
FOOD
FOOD
fruits and
PACKAGING;
counter,
guards; display cases; or other
Condiments, Protection.
Condiments
shall
be protected from contamination
by
23
being kept in dispensers that are designed to provide
24
protection, protected
25
proper
26
dispensing, or individual
27
(B)
UTENSILS,
Condiments at a
FOOD
original
displays provided with the
containers
PACKAGES
designed
for
or portions.
VENDING MACHINE LOCATION
shall be in
28
individual
29
filled at an APPROVED location, such as the FOOD ESTABLISHMENT
30
that provides
PACKAGES
FOOD
78
or provided in dispensers that are
to the
VENDING MACHINE LOCATION,
a
04.05.11
that is regulated by the agency
1
FOOD PROCESSING PLANT
2
that has jurisdiction over
3
equipped facility that
4
VENDING MACHINE LOCATION.
5
3-306.13
6
(A)
7
the operation, or a properly
is located on the site of the
Consumer Self-Service Operations.*
Raw, unPACKAGED animal
POULTRY,
and
8
self-service.
9
(1)
FOOD,
shall not
FISH
CONSUMER
11
raw shellfish;
Ready-to-cook
FOODS
individual
such as sushi or
portions for
13
cooking
14
as
15
ingredients for Mongolian barbecue; or
16
17
(3)
(B)
and
consumption on the
CONSUMER-cooked MEATS
CONSUMER self-service operations for
shall be provided with suitable
19
dispensing
20
contamination.N
(C)
or
PREMISES
methods
that
READY-TO-EAT FOODS
UTENSILS
protect
the
or
23
trained in safe operating procedures.N
24
3-306.14
25
(A)
FOOD
bars shall
be monitored by
from
FOOD EMPLOYEES
Returned Food and Re-Service of Food.*
Except as specified in ¶ (B) of this section, after being
26
served or sold and in the possession of a
27
FOOD
28
not be offered as
30
effective
CONSUMER self-service operations such as buffets and
salad
(B)
such
CONSUMER-selected
22
29
immediate
Raw, frozen, shell-on shrimp, or lobster.
18
21
CONSUMER
self-service of READY-TO-EAT FOODS at buffets
or salad bars that serve
(2)
be offered for
This paragraph does not apply to:
10
12
such as beef, lamb, pork,
that is unused or returned by the
FOOD
CONSUMER,
CONSUMER
shall
for human consumption.
Except as specified under ¶ 3-801.11(G), a container of
FOOD
that is not
POTENTIALLY HAZARDOUS
79
(TIME/TEMPERATURE
1
CONTROL FOR SAFETY FOOD )
2
CONSUMER
3
(1)
The
may be
04.05.11
from one
RE-SERVED
to another if:
is dispensed so that it is protected from
FOOD
4
contamination
and
the
5
between uses,
such
as
6
containing catsup, steak sauce, or wine; or
7
(2)
container
a
closed
narrow-neck bottle
The
FOOD,
such as crackers, salt,
8
in
an
9
maintained in sound condition.
unopened
is
original
or pepper, is
PACKAGE
and
is
10
Preventing
3-307.11
11
Contamination
FOOD shall be protected from contamination that may result
12
from Other
from a factor or source not specified under Subparts 3-301 -
13
Sources
3-306.
Miscellaneous Sources of Contamination.
14
15
16
3-4
DESTRUCTION
OF
ORGANISMS
OF
PUBLIC
HEALTH CONCERN
Subparts
17
3-401
Cooking
18
3-402
Freezing
19
3-403
Reheating
20
3-404
Other Methods
21
22
23
Cooking
3-401.11
(A)
Raw Animal Foods.*
Except as specified under ¶ (B) and in ¶¶ (C) and (D) of
24
this section, raw animal
25
MEAT, POULTRY,
26
FOODS,
and
FOODS
FOODS
such as
EGGS, FISH,
containing these raw animal
shall be cooked to heat all parts of the
FOOD
to
27
a temperature and for a time that complies with one of
28
the following methods based on the
29
cooked:
30
(1)
FOOD
that is being
63oC (145oF) or above for 15 seconds for:
80
1
(a)
Raw
EGGS
04.05.11
that are broken and prepared in
2
response to a
3
immediate service, and
4
(b)
Except
CONSUMER'S
order and for
as specified under Subparagraphs
5
(A)(2) and (A)(3) and ¶ (B), and in ¶ (C) of
6
this section,
7
ANIMALS
8
specified under Subparagraph 3-201.17(A)(1)
9
and
FISH
and
MEAT
including
commercially raised for
GAME
ANIMALS
10
inspection
11
Subparagraph 3-201.17(A)(2);
12
(2)
program
under a
as
GAME
FOOD
as
voluntary
specified
under
68oC (155oF) for 15 seconds or the temperature
13
specified in the following chart that corresponds to
14
the holding time for
15
following if they are
RATITES
and
INJECTED MEATS; the
COMMINUTED: FISH, MEAT, GAME
16
ANIMALS
commercially raised for
17
under
Subparagraph 3-201.17(A)(1), and
18
ANIMALS
under a voluntary inspection program as
19
specified under Subparagraph 3-201.17(A)(2); and
20
raw
EGGS
FOOD
as specified
that are not prepared as specified under
21
Subparagraph (A)(1)(a) of this section:
22
Minimum
23
Temperature
24
Time
o
C (oF)
25
63 (145)
3 minutes
26
66 (150)
1 minute
27
70 (158)
28
29
30
GAME
< 1 second (instantaneous)
;or
(3)
74oC (165oF) or above for 15 seconds for
GAME ANIMALS
POULTRY, BALUTS,
wild
as specified under Subparagraphs 3-201.17(A)(3)
81
1
and
2
POULTRY,
3
POULTRY,
4
(B)
Whole
MEAT
(4),
stuffed
stuffed
or
FISH,
stuffed
RATITES,
MEAT,
or stuffing
stuffed pasta,
containing
04.05.11
stuffed
FISH, MEAT,
RATITES.
roasts including beef, corned beef, lamb, pork, and cured
5
pork roasts such as ham shall be cooked:
6
(1)
In an oven that is preheated to the temperature specified for
7
the roast's weight in the following chart and that is held at that
8
temperature:
9
Oven Type
Oven Temperature Based on Roast Weight
10
Less than 4.5 kg (10 lbs)
4.5 kg (10 lbs) or More
11
Still Dry
177oC (350oF) or more
121oC (250oF) or more
12
Convection
163oC (325oF) or more
121oC (250oF) or more
13
High Humidity1
121oC (250oF) or less
121oC (250oF) or less
14
1
15
exit of the oven; or in a moisture-impermeable bag that provides 100% humidity.
Relative humidity greater than 90% for at least 1 hour as measured in the cooking chamber or
16
17
;and
(2)
As specified in the following chart, to heat all parts of the
FOOD
18
to a temperature and for the holding time that corresponds to
19
that temperature:
20
Temperature
Time1 in
Temperature
Time1 in
Minutes
°C (°F)
Seconds
21
°C (°F)
22
54.4 (130)
112
63.9(147)
134
23
55.0 (131)
89
65.0 (149)
85
24
56.1 (133)
56
66.1 (151)
54
25
57.2 (135)
36
67.2(153)
34
26
57.8 (136)
28
68.3(155)
22
27
58.9 (138)
18
69.4 (157)
14
28
60.0 (140)
12
70.0 (158)
0
29
61.1 (142)
8
82
1
2
3
4
62.2 (144)
5
62.8 (145)
4
04.05.11
1
Holding time may include postoven heat rise.
(C)
A raw or undercooked
WHOLE-MUSCLE,
5
served or offered for sale in a READY-TO-EAT form if:
6
(1)
7
8
FOOD ESTABLISHMENT
serves
a population that
is not a
HIGHLY SUSCEPTIBLE POPULATION,
(2)
The
steak is labeled to indicate that it meets the definition
“WHOLE-MUSCLE,
9
10
11
The
steak may be
INTACT BEEF
INTACT BEEF”
of
as specified under ¶ 3-201.11(E),
and
(3)
The steak is cooked on both the top and bottom to a surface
63oC (145oF) or above and a cooked color
12
temperature
13
change is achieved on all external surfaces.
14
(D)
A
of
raw
animal
FOOD
such
as raw
EGG,
raw
FISH,
raw-
15
marinated
16
or a partially cooked
17
soft
18
MUSCLE, INTACT
19
section, may be served or offered for sale upon CONSUMER
20
request or selection in a
21
(1)
22
cooked
raw
MOLLUSCAN SHELLFISH,
EGGS,
BEEF
FOOD
MEAT
other than
FISH,
WHOLE-
steaks as specified in ¶ (C) of this
READY-TO-EAT
form if:
As specified under ¶¶ 3-801.11(C)(1) and (2), the
a
(2)
or steak tartare;
such as lightly cooked
or rare
FOOD ESTABLISHMENT
23
24
FISH,
serves a population that is not
HIGHLY SUSCEPTIBLE POPULATION ;
The
CONSUMER
and
is informed as specified under § 3-
25
603.11 that to ensure its safety, the
26
be cooked as specified under ¶ (A) or (B) of this section;
27
or
28
(3)
The
REGULATORY
AUTHORITY
FOOD
grants
a
should
VARIANCE
29
from ¶ (A) or (B) of this section as specified in § 8-
30
103.10 based on a HACCP
83
PLAN
that:
1
04.05.11
Is submitted by the PERMIT HOLDER and APPROVED
(a)
2
as specified under § 8-103.11,
3
(b)
Documents
scientific
data
or
other
4
information showing that a lesser time and
5
temperature regimen results in a safe
6
and
7
(c)
Verifies that
8
EQUIPMENT
FOOD preparation
9
at
10
the
conditions of the
3-401.12
Microwave Cooking.*
12
Raw animal
FOODS
13
(A)
and procedures for
and training of FOOD EMPLOYEES
FOOD
11
FOOD,
ESTABLISHMENT
meet the
VARIANCE.
cooked in a microwave oven shall be:
Rotated or stirred throughout or midway during cooking
to compensate for uneven distribution of heat;
14
15
(B)
Covered to retain surface moisture;
16
(C)
Heated to a temperature of at least 74oC (165oF) in all
17
parts of the
18
(D)
19
FOOD;
and
Allowed to stand covered for 2 minutes after cooking to
obtain temperature equilibrium.
20
3-401.13
21
Fruits and vegetables that are cooked for hot holding shall be
22
cooked to a temperature of 60oC (140oF)
23
24
Freezing
3-402.11
(A)
Plant Food Cooking for Hot Holding.
Parasite Destruction.*
Except
as
specified in ¶ (B) of this section, before
25
service or sale in
26
partially cooked, or marinated-partially cooked
27
be:
84
READY-TO-EAT
form, raw, raw-marinated,
FISH
shall
1
(1)
04.05.11
Frozen and stored at a temperature of -20°C (-4°F)
2
or below for a minimum of 168 hours (7 days) in
3
a freezer;
4
(2)
Frozen at -35°C (-31°F) or below until solid and
5
stored at -35°C (-31°F) or below for a minimum of
6
15 hours; or
7
(3)
Frozen at -35°C (-31°F) or below until solid and
8
stored at -20°C (-4°F) or below for a minimum of
9
24 hours.
10
(B)
Paragraph (A) of this section does not apply to:
11
(1)
MOLLUSCAN
SHELLFISH;
12
(2)
Tuna of the species Thunnus alalunga, Thunnus
13
albacares
(Yellowfin
tuna),
14
Thunnus
maccoyii
(Bluefin
15
Thunnus
obesus
16
thynnus (Bluefin tuna, Northern); or
17
(3)
18
Aquacultured
(a)
FISH,
(Bigeye
Thunnus
tuna,
tuna),
atlanticus,
Southern),
or
Thunnus
such as salmon, that:
If raised in open water, are raised in net-pens,
19
or
20
(b)
Are raised in land-based operations such as
21
ponds or tanks, and
22
(c)
Are fed formulated feed, such as pellets,
23
that contains no live parasites infective to
24
the aquacultured
25
3-402.12
26
(A)
FISH.
Records, Creation and Retention.
Except as specified in ¶ 3-402.11(B) and ¶ (B) of this
27
section,
if raw,
raw-marinated,
28
marinated-partially cooked
29
READY-TO-EAT
30
freezing temperature
form, the
85
FISH
partially cooked,
are served or sold in
PERSON IN CHARGE
and
or
shall record the
time to which the
FISH
are
1
04.05.11
subjected and shall retain the records of the FOOD
2
ESTABLISHMENT
3
service or sale of the
4
(B)
If the
FISH
for 90 calendar days beyond the time of
FISH.
are frozen by a supplier, a written agreement
5
or statement from the supplier stipulating that the
6
supplied are frozen to a temperature and for a time
7
specified under § 3-402.11 may substitute for the records
8
specified under ¶ (A) of this section.
9
(C)
FISH
If raw, raw-marinated, partially cooked, or marinated-
10
partially cooked
11
form, and the
12
Subparagraph 3-402.11 (B)(3), a written agreement or
13
statement
14
that the
15
Subparagraph 3-402.11(B)(3) shall
16
PERSON IN CHARGE
and retained in the records of the
17
FOOD ESTABLISHMENT
for 90 calendar days beyond the time
FISH
are served or sold in
are
FISH
raised
FISH
were raised and
3-403.10
20
Cooked and refrigerated
21
service in response to an individual
22
a roast
23
temperature.
25
Reheating
3-403.11
(A)
fed
as
specified in
be obtained by
the
FISH.
19
24
and fed as specified in
from the supplier or aquaculturist stipulating
of service or sale of the
18
READY-TO-EAT
Preparation for Immediate Service.
beef
FOOD
sandwich
that is prepared for immediate
au jus,
order, such as
CONSUMER
may
be
served
at
any
Reheating for Hot Holding.*
Except as specified under ¶¶ (B) and (C) and in ¶ (E)
26
of
this
section,
27
(TIME/TEMPERATURE
28
cooked, cooled, and reheated for hot holding shall be
29
reheated so that
30
temperature of at least 74oC (165oF) for 15 seconds.
86
POTENTIALLY
CONTROL
all
FOR
parts of
HAZARDOUS
SAFETY
the
FOOD)
FOOD
FOOD
that is
reach
a
1
(B)
Except
as
specified
under
¶ (C)
of
04.05.11
section,
this
2
POTENTIALLY HAZARDOUS FOOD (TIME/TEMPERATURE CONTROL FOR
3
SAFETY FOOD)
4
holding shall be
5
FOOD
6
the
7
stand covered for 2 minutes after reheating.
8
(C)
9
reheated in a microwave oven for hot
reheated so that
all
parts
of
reach a temperature of at least 74oC (165oF) and
FOOD
is rotated or stirred, covered, and allowed to
READY-TO-EAT
taken from a commercially processed,
FOOD
HERMETICALLY SEALED CONTAINER,
or from an
10
intact package from a
11
inspected by the
12
jurisdiction over
13
temperature of at least 60oC (140oF) for hot holding.
14
(D)
the
FOOD PROCESSING PLANT
FOOD REGULATORY AUTHORITY
the
plant,
shall
be
that is
that has
heated
to
a
Reheating for hot holding as specified under ¶¶ (A) - (C)
15
of this section shall be done rapidly and the time the
16
FOOD
17
specified
18
exceed 2 hours.
19
(E)
is
between
5°C (41°F)
and
the temperatures
under ¶¶ (A) - (C) of this section shall not
Remaining unsliced portions of
MEAT
roasts that are
20
cooked
21
reheated for hot holding using the oven parameters and
22
minimum time and temperature conditions specified under
23
¶ 3-401.11(B).
24
Other Methods
3-404.11
as
specified
under
¶ 3-401.11(B)
may
be
Treating Juice.
25
JUICE
PACKAGED
in a
26
(A)
Treated under
FOOD ESTABLISHMENT
a
HACCP
PLAN
shall be:
as specified in ¶¶
8-
27
201.12(B) - (E) to attain a 5-log reduction, which is equal
28
to a
29
microorganism of public health significance; or
30
(B)
99.999%
reduction,
of
the
most
resistant
Labeled, if not treated to yield a 5-log reduction of the
87
resistant
microorganism
of
public
04.05.11
health
1
most
2
significance:
3
(1)
As specified under § 3-602.11, and
4
(2)
As specified in 21 CFR 101.17(g) Food labeling,
5
warning,
6
Juices that have not been specifically processed
7
to prevent,
8
pathogens with
9
product has not been pasteurized and, therefore,
notice, and
contain
safe
handling
statements,
reduce, or eliminate the presence of
the following,
harmful
“WARNING:
10
may
11
serious
12
persons with weakened immune systems.”
illness in
bacteria
children,
This
that can cause
the elderly, and
13
14
15
3-5
LIMITATION OF GROWTH OF ORGANISMS OF PUBLIC HEALTH CONCERN
Subparts
16
3-501
Temperature and Time Control
17
3-502
Specialized Processing Methods
Frozen Food.
18
19
Temperature
3-501.11
20
and Time
Stored frozen
21
Control
22
3-501.12
23
FOODS
Potentially Hazardous Food Time/Temperature
Control for Safety Food), Slacking.
24
Frozen
25
FOR SAFETY FOOD)
26
shall be held:
27
(A)
28
29
30
shall be maintained frozen.
POTENTIALLY HAZARDOUS FOOD (TIME/TEMPERATURE CONTROL
that is slacked to moderate the temperature
Under refrigeration that maintains the FOOD temperature
at 5°C (41°F) or less; or
(B)
At any temperature if the
3-501.13
Thawing.
88
FOOD
remains frozen.
as specified
Except
2
HAZARDOUS FOOD (TIME/TEMPERATURE CONTROL FOR SAFETY FOOD)
3
be thawed:
4
(A)
5
6
in
¶ (D) of
this
section,
04.05.11
1
Under refrigeration that maintains the
FOOD
POTENTIALLY
shall
temperature
at 5°C (41°F) or less; or
(B)
Completely submerged under running water:
7
(1)
At a water temperature of 21°C (70°F) or below,
8
(2)
With sufficient water velocity to agitate and float
9
off loose particles in an overflow, and
10
(3)
For a period of time that does not allow thawed
11
portions of READY-TO-EAT FOOD to rise above 5°C (41°F),
12
or
13
(4)
For a period of time that does not allow thawed
14
portions of a raw animal
15
specified under ¶ 3 401.11(A) or (B) to be above
16
5°C (41°F) for more than 4 hours including:
17
(a)
The
time
the
requiring cooking as
FOOD
FOOD
is
exposed
to the
18
running water and the time needed for
19
preparation for cooking, or
20
(b)
21
22
lower the
(C)
FOOD
is:
24
(1)
25
refrigeration to
temperature to 5°C (41°F);
As part of a cooking process if the
23
26
The time it takes under
FOOD
that is frozen
Cooked as specified under ¶ 3-401.11(A) or (B) or
§ 3-401.12, or
(2)
Thawed in a microwave oven and immediately
27
transferred
28
with no interruption in the process; or
89
to conventional
cooking
EQUIPMENT,
1
(D)
04.05.11
Using any procedure if a portion of frozen
2
FOOD
3
response to an individual
4
3-501.14
5
(A)
is thawed and prepared for immediate service in
order.
POTENTIALLY HAZARDOUS FOOD (TIME/TEMPERATURE
6
CONTROL FOR SAFETY FOOD)
7
(1)
shall be cooled:
Within 2 hours from 57°C (135°F) to 21°C (70°F);
and
9
(2)
Within a total of 6 hours from 57°C (135°F) to
5°C (41°F) or less.
10
11
CONSUMER'S
Cooling.*
Cooked
8
READY-TO-EAT
(B)
POTENTIALLY HAZARDOUS FOOD (TIME/TEMPERATURE CONTROL FOR
12
SAFETY FOOD)
13
or less if prepared from ingredients at ambient temperature,
14
such as reconstituted
15
(C)
Except
as
shall be cooled within 4 hours to 5°C (41°F)
FOODS
specified
and canned tuna.
under ¶ (D) of this section,
a
16
POTENTIALLY HAZARDOUS FOOD (TIME/TEMPERATURE CONTROL FOR
17
SAFETY FOOD)
18
received in compliance with
LAWS
temperature above 5°C (41°F) during shipment from the
19
supplier as specified in ¶ 3 202.11(B), shall
20
within 4 hours to 5°C (41°F) or less.
21
allowing a
(D)
Raw
EGGS
shall be received as specified under ¶ 3-
22
202.11(C)
23
EQUIPMENT
24
7oC (45oF) or less.
25
3-501.15
26
(A)
be cooled
and
immediately
placed
in
refrigerated
that maintains an ambient air temperature of
Cooling Methods.
Cooling shall be accomplished in accordance with the
27
time and temperature criteria specified under § 3-501.14
28
by using one or more of the following methods based
29
on the type of
30
(1)
FOOD
Placing the
90
being cooled:
FOOD
in shallow pans;
1
(2)
Separating
2
the
FOOD
into
smaller
04.05.11
thinner
or
portions;
3
(3)
Using rapid cooling
4
(4)
Stirring the
5
FOOD
EQUIPMENT;
in a container placed in an ice
water bath;
6
(5)
Using containers that facilitate heat transfer;
7
(6)
Adding ice as an ingredient; or
8
(7)
Other effective methods.
9
(B)
When placed in cooling or cold holding
10
containers in which
11
(1)
FOOD
Arranged in the
12
EQUIPMENT, FOOD
is being cooled shall be:
EQUIPMENT
to provide maximum
heat transfer through the container walls; and
13
(2)
Loosely covered, or uncovered if protected from
14
overhead
15
Subparagraph 3-305.11(A)(2), during the cooling
16
period to facilitate heat transfer from the surface
17
of the
18
3-501.16
as
specified
under
FOOD.
Potentially Hazardous
19
20
contamination
Food (Time/Temperature
Control for Safety Food), Hot and Cold Holding.*
(A)
Except during preparation, cooking, or cooling, or when time
21
is used as the public health control as specified under §3
22
501.19, and except as specified under ¶ (B) and in ¶ (C
23
)
24
(TIME/TEMPERATURE CONTROL FOR SAFETY FOOD)
25
maintained:
26
(1)
of
this
section,
POTENTIALLY
HAZARDOUS
FOOD
shall be
At 60°C (140°F) or above, except that roasts
27
cooked to a temperature and for a time specified
28
in ¶ 3 401.11(B) or reheated as specified in ¶ 3-
29
403.11(E) may be held at a temperature of 54°C
30
(130°F) or above; or
91
1
2
(B)
3
04.05.11
(2)
At 5°C (41°F) or less.
EGGS
that have not been treated to destroy all viable
shall be stored in refrigerated
SALMONELLAE
EQUIPMENT
that
4
maintains an ambient air temperature of 7°C (45°F) or
5
less.
6
(C)
POTENTIALLY HAZARDOUS FOOD (TIME/TEMPERATURE CONTROL FOR
7
SAFETY FOOD)
in a homogenous liquid
8
maintained
9
requirements, as specified under ¶ (A) of this section,
outside
of
the
form
temperature
may be
control
10
while contained within specially designed
11
complies with the design and construction requirements
12
as specified under ¶ 4-204.13(E).
13
3-501.17
Ready-to-Eat,
Potentially
14
(Time/Temperature
15
Date Marking.*
16
on-premises
17
preparation
18
19
(A)
Except when
Hazardous
Control
PACKAGING FOOD
EQUIPMENT
for Safety Food),
using a
REDUCED OXYGEN
except as specified in ¶¶ (D) and (E) of
refrigerated,
hold cold
20
Food
method as specified under § 3-502.12, and
PACKAGING
prepare and
that
READY-TO-EAT,
POTENTIALLY
this section,
HAZARDOUS FOOD
prepared and
(TIME/TEMPERATURE CONTROL FOR SAFETY FOOD)
21
held in a
22
shall be clearly marked to indicate the date or day by
23
which the
24
or discarded when held at a temperature of 5°C (41°F)
25
or less for a maximum of 7 days.
26
commercially
27
Processed food
28
29
30
open and
hold cold
(B)
FOOD ESTABLISHMENT
FOOD
Except as
refrigerated,
shall be consumed on the
specified
in ¶¶ (D) - (F) of
READY-TO-EAT,
(TIME/TEMPERATURE
PACKAGED
by a
for more than 24 hours
PREMISES,
this
sold,
section,
POTENTIALLY HAZARDOUS FOOD
CONTROL FOR SAFETY FOOD)
FOOD PROCESSING
PLANT
prepared and
shall be clearly
marked, at the time the original container is opened in
92
a
2
than 24 hours, to indicate the date or day by which
3
the
4
discarded, based
5
combinations specified in (A) of this section and:
6
(1)
FOOD ESTABLISHMENT
7
and if the
04.05.11
is held for more
1
shall be consumed on the
FOOD
on
the
(2)
9
PREMISES,
temperature
sold, or
and
The
day
or
ESTABLISHMENT
shall be counted as Day 1; and
date
marked
by
the
use-by date if the manufacturer determined
11
use-by date based on
(C)
A refrigerated,
FOOD
may not exceed a manufacturer’s
10
12
time
The day the original container is opened in the
FOOD ESTABLISHMENT
8
FOOD
FOOD
the
safety.
READY-TO-EAT, POTENTIALLY HAZARDOUS FOOD
13
(TIME/TEMPERATURE
14
or a portion of a refrigerated,
15
HAZARDOUS FOOD (TIME/TEMPERATURE CONTROL FOR SAFETY FOOD)
16
that is subsequently combined with additional ingredients or
17
portions of
18
earliest-prepared or first-prepared ingredient.
19
(D)
FOOD
CONTROL FOR SAFETY FOOD)
ingredient
READY-TO-EAT, POTENTIALLY
shall retain the date marking of the
A date marking system that meets the criteria stated in ¶¶
20
(A) and (B) of this section may include:
21
(1)
Using a method
APPROVED
by the
REGULATORY
22
AUTHORITY
23
HAZARDOUS
24
SAFETY FOOD)
25
lunchmeat or a roast, or for which date marking
26
is
27
dispensing machine;
28
(2)
for refrigerated,
FOOD
READY-TO-EAT POTENTIALLY
(TIME/TEMPERATURE
CONTROL
FOR
that is frequently rewrapped, such as
impractical, such as soft serve mix or milk in a
Marking the date or day of preparation, with a
29
procedure to discard the
30
last
date or
93
day
by
FOOD
which
or on before the
the
FOOD
must be
1
04.05.11
consumed on the premises, sold, or discarded as
2
specified under ¶ (A) of this section;
3
(3)
Marking
the date or day the original container is
4
opened in a
5
to discard the
6
day by which the
7
premises, sold, or discarded as specified under ¶
8
(B) of this section; or
9
(4)
FOOD ESTABLISHMENT,
FOOD
with a procedure
on or before the last date or
FOOD
must be consumed on the
Using calendar dates, days of the week, color-
10
coded marks, or other effective marking methods,
11
provided that the marking system is disclosed to
12
the
13
(E)
REGULATORY AUTHORITY
upon request.
Paragraphs (A) and (B) of this section do not apply to individual
14
meal portions served or repackaged for sale from a bulk
15
container upon a consumer’s request.
16
(F)
Paragraph (B) of this section does not apply to the
17
following FOODS prepared and PACKAGED by a FOOD PROCESSING
18
PLANT
19
(1)
inspected by a
REGULATORY AUTHORITY:
Deli salads, such
as
ham salad, seafood salad,
20
chicken
21
salad, and
22
accordance with
23
manufacturing practice in manufacturing, packing,
24
or holding human food;
25
(2)
Hard
salad, egg salad, pasta salad, potato
macaroni
cheeses
salad,
manufactured
21 CFR 110
containing
not
Current
in
good
more than 39%
26
moisture as defined in 21 CFR 133 Cheeses and
27
related
28
gruyere, parmesan and reggiano, and romano;
29
30
(3)
cheese
Semi-soft
cheeses
moisture, but
94
products,
not
such
as
cheddar,
containing more than 39%
more than 50%
moisture,
as
04.05.11
and related
1
defined
2
cheese products, such as blue, edam, gorgonzola,
3
gouda, and monterey jack;
4
(4)
in
Cultured dairy products as defined in 21 CFR 131
5
Milk and
6
buttermilk;
7
(5)
21 CFR 133 Cheeses
cream, such as yogurt, sour cream, and
Preserved
products, such as pickled herring
FISH
8
and dried or salted cod, and other acidified
9
products defined in 21 CFR 114 Acidified foods;
10
(6)
FISH
Shelf stable, dry fermented sausages, such as
11
pepperoni and Genoa salami that are not labeled
12
“Keep Refrigerated” as specified in 9 CFR 317 Labeling,
13
marking devices, and containers, and which retain
14
the original
15
(7)
CASING
on the product; and
Shelf stable salt-cured products such as prosciutto
16
and Parma (ham) that are not labeled “Keep
17
Refrigerated” as specified in 9 CFR 317 Labeling,
18
marking devices, and containers.
19
3-501.18
Ready-to-Eat,
Potentially
20
(Time/Temperature Control
21
Disposition.*
22
(A)
A
FOOD
Hazardous
for
discarded if it:
24
(1)
Exceeds
either
of
the
temperature
25
combinations
26
time that the product is frozen;
(2)
28
29
30
Food),
specified in ¶ 3-501.17(A) or (B) shall be
23
27
Safety
Food
and
time
specified in ¶ 3-501.17(A), except
Is in a container or
PACKAGE
that does not bear
a date or day; or
(3)
Is appropriately
marked with a date or day that
exceeds a temperature and time combination as
95
1
04.05.11
specified in ¶ 3-501.17(A).
2
(B)
Refrigerated,
READY-TO-EAT, POTENTIALLY HAZARDOUS FOOD
3
(TIME/TEMPERATURE
4
a
CONTROL FOR SAFETY FOOD)
and dispensed through a
FOOD ESTABLISHMENT
5
MACHINE
6
discarded if
7
combination as specified in ¶ 3-501.17(A).
8
3-501.19
9
Deleted.
with an
it
Specialized
3-502.11
11
Processing
A
12
Methods
REGULATORY AUTHORITY
exceeds
ESTABLISHMENT
§ 8-103.11 before:
14
(A)
Smoking
a
temperature
and
time
FOOD
shall obtain a
VARIANCE
from
the
as specified in § 8-103.10 and under
as a method of
FOOD
preservation rather
than as a method of flavor enhancement;
16
(B)
Curing
17
(C)
Using
FOOD;
FOOD ADDITIVES
18
vinegar:
19
(1)
20
As a method of
or adding
FOOD
components such
as
preservation rather than as a
method of flavor enhancement, or
21
(2)
To render a
22
HAZARDOUS
23
FOOD);
24
automatic shutoff control shall be
Variance Requirement.*
13
15
VENDING
Time as a Public Health Control.*
10
FOOD
prepared in
(D)
FOOD
so that it is not
(TIME/TEMPERATURE
Packaging FOOD using a
POTENTIALLY
CONTROL OF SAFETY
REDUCED OXYGEN PACKAGING method
25
except as specified under § 3-502.12 where a barrier to
26
Clostridium botulinum in addition to refrigeration exists;
27
(E)
Operating a
MOLLUSCAN SHELLFISH
life-support
system
28
display tank used to store and display shellfish that are
29
offered for human consumption;
30
(F)
Custom processing animals that are for personal use
96
1
as
2
ESTABLISHMENT;
3
(G)
Preparing
by the
4
5
(H)
and
FOOD
not
for
sale
or service
04.05.11
a FOOD
in
by another method that is determined
FOOD
to require a
REGULATORY AUTHORITY
VARIANCE;
or
Sprouting seeds or beans.
6
Clostridium
3-502.12
7
botulinum and
(A)
8
Listeria
as specified under § 3-502.11 and except as specified
9
Monocytogenes
under ¶¶ (C) and (E) and as specified in ¶ (D) of this
Controls
section, a
10
Reduced Oxygen Packaging, Criteria.*
Except for a
FOOD ESTABLISHMENT
FOOD ESTABLISHMENT
that obtains a
that
VARIANCE
PACKAGES POTENTIALLY
11
HAZARDOUS
12
FOOD)
13
ensure that there are at least two barriers in place to
14
control the growth and
15
botulinum and the growth of Listeria monocytogenes.
16
(B)
A
FOOD
using a
(TIME/TEMPERATURE
CONTROL FOR SAFETY
REDUCED OXYGEN PACKAGING
FOOD ESTABLISHMENT
toxin
method shall
of Clostridium
formation
that PACKAGES POTENTIALLY HAZARDOUS
17
FOOD (TIME/TEMPERATURE CONTROL FOR SAFETY FOOD)
using a
18
REDUCED OXYGEN PACKAGING
19
PLAN
20
8-201.14(D) and that:
21
(1)
Identifies the
22
(2)
Except as specified under ¶¶ (C) and (E) and as
method shall have a HACCP
that contains the information specified under ¶
FOOD
to be
PACKAGED;
23
specified in ¶ (D) of this section, requires that the
24
PACKAGED FOOD
25
or less and meet at least one of the following
26
criteria:
shall be maintained at 5°C (41°F)
27
(a)
Has an
28
(b)
Has a
29
(c)
Is a
30
a
97
AW
PH
MEAT
FOOD
of 0.91 or less,
of 4.6 or less,
or
POULTRY
product cured at
PROCESSING PLANT
regulated
by
2
specified
3
food
4
radiation, and is received in an intact
5
PACKAGE,
6
(d)
the USDA
04.05.11
substances
1
Is
using
in 9 CFR 424.21, Use of
ingredients
a
and
sources
of
or
with a high level of
FOOD
7
competing organisms such as raw MEAT
8
or raw
9
(3)
POULTRY;
Describes how the
PACKAGE
shall be prominently
10
and conspicuously labeled on the principal display
11
panel in bold type on a contrasting background,
12
with instructions to:
13
(a)
14
Maintain the
FOOD
at 5oC (41oF) or below,
and
15
(b)
Discard
the
if
within 14 calendar
PACKAGING
it is not served for
FOOD
16
days of its
17
on-PREMISES
18
served or sold for off-PREMISES consumption;
19
(4)
consumption,
or
consumed if
Limits the refrigerated shelf life to no more than
20
14 calendar days from
21
except the time the product is maintained frozen,
22
or the original manufacturer’s “sell by” or “use by”
23
date, whichever occurs first;
24
(5)
PACKAGING
to consumption,
Includes operational procedures that:
25
(a)
Prohibit contacting
26
(b)
Identify
a
FOOD
designated
27
method by which:
28
(i)
Physical
barriers
with bare hands,
work
area and the
or
methods
29
separation of raw
FOODS
30
TO-EAT
minimize
98
FOODS
and
of
READY-
cross
1
04.05.11
contamination, and
2
(ii)
Access to
the processing
3
is
4
personnel familiar with the potential
5
HAZARDS
6
(c)
Delineate
7
limited
EQUIPMENT
of the operation, and
cleaning
procedures for
8
(6)
9
to responsible trained
and
SANITIZATION
FOOD-CONTACT SURFACES;
and
Describes the training program that ensures that
the individual responsible for the
REDUCED OXYGEN
10
PACKAGING
11
(a)
Concepts required for a safe operation,
12
(b)
EQUIPMENT and facilities, and
13
(c)
Procedures specified under Subparagraph
14
15
operation understands the:
(B)(5) of this section and ¶ 8-201.14(D).
Fish
(C)
Except for
16
PACKAGING,
17
using a
18
Cook-Chill or
19
Sous Vide
(D)
FISH
a
that is frozen before, during, and after
FOOD ESTABLISHMENT
shall not
REDUCED OXYGEN PACKAGING
PACKAGE FISH
method.
Except as specified under ¶ (C) of this section, a
ESTABLISHMENT
may package
FOOD
using a cook-chill or
20
sous vide process without obtaining a
21
(1)
The
FOOD ESTABLISHMENT
FOOD
VARIANCE
if:
implements a HACCP
PLAN
22
that contains the information as specified under ¶ 8-
23
201.14(D);
24
25
(2)
The
(a)
FOOD
is:
Prepared and
consumed on the
PREMISES,
26
or prepared and consumed off the
27
but within the same business entity with no
28
distribution or sale of the bagged product to
29
another business entity or the
30
(b)
CONSUMER,
Cooked to heat all parts of the
99
PREMISES
FOOD
to a
1
04.05.11
temperature and for a time as specified
2
under § 3-401.11,
3
(c)
4
5
Protected from contamination after cooking
as specified under Part 3-4,
(d)
Placed in a package or bag with an oxygen
6
barrier and sealed before cooking, or placed
7
in
8
immediately
9
reaching a temperature below 57°C (135°F),
10
(e)
a
PACKAGE
after
or
bag
and
sealed
cooking,
and
before
Cooled to 5°C (41°F) in the sealed
PACKAGE
11
or bag as specified under §3-501.14, and
12
subsequently:
13
(i)
Cooled to 1°C (34°F) within 48 hours
14
of reaching 5°C (41°F) and held at
15
that temperature until
16
discarded within 30 days after the
17
date of preparation;
18
(ii)
consumed
or
Cooled to 1°C (34°F) within 48 hours
19
of reaching 5°C (41°F), removed from
20
refrigeration equipment that maintains
21
a 1°C (34°F) food temperature and
22
then held at 5°C (41°F) or less for no
23
more than 72 hours, at which time the
24
FOOD
25
discarded;
26
(iii)
must
be
consumed
or
Cooled to 3°C (38°F) or less within
27
24 hours of reaching 5°C (41°F) and
28
held there for no more than 72 hours
29
from packaging, at which time the
30
food
100
must
be
consumed
or
04.05.11
1
discarded; or
2
(iv)
Held
frozen
with
no
shelf
life
3
restriction while frozen until consumed
4
or used.
5
(f)
Held in a refrigeration unit that is equipped
6
with an electronic system that continuously
7
monitors
8
visually examined for proper operation twice
9
daily,
10
(g)
time
and
temperature
and
is
If transported off-site to a satellite location of
11
the same business entity, equipped with
12
verifiable electronic
13
ensure that times and temperatures are
14
monitored during transportation, and
15
(h)
16
Labeled
date
17
(3)
monitoring devices to
with the product name and the
PACKAGED;
and
The records required to confirm that cooling and
18
cold
19
parameters are required as part of the HACCP
20
PLAN,
21
(a)
22
holding
refrigeration
time/temperature
are maintained and are:
Made available to the
REGULATORY AUTHORITY
upon request, and
23
(b)
24
(4)
Held for 6 months; and
Written operational procedures as specified under
25
Subparagraph (B)(5) of this section and a training
26
program as specified under Subparagraph (B)(6) of
27
this section are implemented.
28
Cheese
(E)
A FOOD ESTABLISHMENT may
29
OXYGEN PACKAGING
30
(1)
method without obtaining a VARIANCE if it:
Limits the cheeses
101
PACKAGE cheese using a REDUCED
PACKAGED
to
those that
are
1
04.05.11
commercially manufactured in a FOOD PROCESSING PLANT
2
with no ingredients added in the
3
and that meet the Standards of Identity as specified in
4
21 CFR 133.150 Hard cheeses, 21 CFR 133.169
5
Pasteurized process cheese or 21 CFR 133.187
6
Semisoft cheeses;
7
(2)
8
Has a HACCP
FOOD ESTABLISHMENT
that contains the
PLAN
information
specified under ¶ 8-201.14(D);
9
(3)
Except as specified under Subparagraphs (B)(2),
10
(B)(3)(b), and (B)(4), complies
11
section;
12
(4)
Labels the
PACKAGE
with ¶ (B) of this
on the principal display panel
13
with a
14
days or
15
“use by” date, whichever occurs first; and
16
(5)
“use by” date that does not exceed 30
the original manufacturer’s “sell by” or
Discards the
REDUCED OXYGEN PACKAGED
cheese
17
if it is not sold for off-PREMISES consumption or
18
consumed
19
PACKAGING.
within
30
calendar
days
of
its
20
21
22
3-6 FOOD IDENTITY, PRESENTATION, AND ON-PREMISES LABELING
Subparts
23
3-601
Accurate Representation
24
3-602
Labeling
25
3-603
Consumer Advisory
Standards of Identity
26
27
Accurate
3-601.11
28
Representation
PACKAGED
29
FOOD
shall
comply
with standard
of
identity
requirements and standards of identity or composition, and the
102
1
04.05.11
general requirements in 21 CFR 130 – Food Standards: General
2
and 9 CFR 319 Subpart A – General.
3
3-601.12
4
(A)
5
Honestly Presented.
FOOD shall be offered for human consumption in a way
that does not mislead or misinform the
6
(B)
FOOD or
COLOR ADDITIVES,
CONSUMER.
colored overwraps, or lights
7
shall not be used to misrepresent the true appearance,
8
color, or quality of a
9
10
Labeling
3-602.11
Food Labels.
(A)
PACKAGED
11
FOOD
as
in a
specified in
FOOD.
FOOD ESTABLISHMENT,
LAW ,
including
shall be labeled
21 CFR 101 - Food
12
labeling, and 9 CFR 317 Labeling, marking devices, and
13
containers.
14
15
(B)
Label information shall include:
(1)
16
17
The common name of the FOOD, or absent a common
name, an adequately descriptive identity statement;
(2)
If made from two or more ingredients, a list of
18
ingredients in descending order of predominance
19
by weight, including a declaration of artificial color
20
or flavor and chemical preservatives, if contained
21
in the
22
(3)
23
24
accurate
declaration
of
the
quantity
of
contents;
(4)
25
26
An
FOOD;
The name and place of business of the manufacturer,
packer, or distributor; and
(5)
The name of the
FOOD
source for each
contained in the
MAJOR
27
FOOD ALLERGEN
28
FOOD
29
usual name of the respective ingredient (Effective
30
January 1, 2006).
FOOD
unless the
source is already part of the common or
103
1
(6)
04.05.11
Except as exempted in the Federal Food, Drug,
2
and
3
labeling
4
Labeling
5
Labeling.
6
(7)
Cosmetic
as
Act § 403(Q)(3) - (5),
specified
and
in
9 CFR 317
For any salmonid
21 CFR 101 - Food
Subpart B
Nutrition
containing canthaxanthin
FISH
7
as a
8
container, including a list of ingredients, displayed
9
on the retail container or by other written means,
10
such as a counter card, that discloses the use of
11
canthaxanthin.
12
(C)
COLOR ADDITIVE,
nutrition
the labeling of the bulk
Bulk
FOOD
13
shall
be
14
information in plain view of the
15
(1)
16
that is available for
prominently
(2)
labeled
self-dispensing
with
the
following
CONSUMER:
The manufacturer's or processor's label that was
provided with the
17
CONSUMER
FISH
FOOD;
or
A card, sign, or other method of notification that
18
includes
19
Subparagraphs (B)(1), (2), and (5) of this section.
20
(D)
the
Bulk, unPACKAGED
information
FOODS
unPACKAGED
22
specification need not be labeled if:
23
(1)
24
25
portioned
to
CONSUMER
A health, nutrient content, or other claim is not
(2)
There are no state or local
LAWS
requiring labeling;
and
(3)
The
FOOD
is manufactured or prepared on
28
PREMISES
29
FOOD ESTABLISHMENT
30
are
made;
26
27
that
under
such as bakery products and
21
FOODS
specified
of the
FOOD ESTABLISHMENT
or a
is owned by the same
104
the
or at another
FOOD PROCESSING PLANT that
PERSON
and is regulated by
04.05.11
the FOOD regulatory agency that has jurisdiction.
1
2
3-602.12
3
(A)
If required by
4
(B)
FOOD
5
on
6
Consumer
7
Advisory
Other Forms of Information.
shall not be concealed or altered.
Consumption of Animal Foods that are Raw,
Undercooked, or Not Otherwise Processed to
8
9
warnings shall be provided.
or manufacturers' dating information
ESTABLISHMENT
FOODS
3-603.11
LAW , CONSUMER
Eliminate Pathogens.*
(A)
Except as specified in ¶ 3-401.11(C) and Subparagraph
10
3-401.11(D)(3)
11
FOOD
and
such as beef,
under ¶ 3-801.11(C), if an animal
EGGS, FISH,
lamb, milk, pork,
POULTRY,
12
or shellfish is served or sold raw, undercooked, or without
13
otherwise being processed to eliminate pathogens, either
14
in
READY-TO-EAT
form or as an ingredient in another
15
READY-TO-EAT FOOD,
16
CONSUMERS
of
17
consuming
such
18
REMINDER,
19
using brochures, deli case or menu advisories, label
20
statements, table tents, placards,
21
written means.
22
23
(B)
the
the
PERMIT
HOLDER
significantly
FOODS
shall
increased
by way of
a
inform
RISK
DISCLOSURE
of
and
as specified in ¶¶ (B) and (C) of this section
or
other effective
DISCLOSURE shall include:
(1)
A description of the animal-derived
FOODS,
such
24
as “oysters on the half shell (raw oysters),” “raw-
25
EGG
26
cooked to order);” or
27
(2)
Caesar salad,”
Identification
of
the
and
“hamburgers (can be
animal-derived
FOODS
by
28
asterisking them to a footnote that states that the
29
items are served raw or undercooked, or contain
30
(or may contain) raw or undercooked ingredients.
105
1
(C)
REMINDER shall
2
FOODS
3
(1)
requiring
include
asterisking
to a footnote that states:
DISCLOSURE
Regarding
the
04.05.11
animal-derived
the
safety
of
these
items,
written
information is available upon request;
4
5
(2)
Consuming raw or undercooked
6
seafood,
7
RISK
8
(3)
shellfish, or
may
EGGS
increase your
of foodborne illness; or
Consuming raw or undercooked
9
MEATS, POULTRY,
seafood,
shellfish, or
of foodborne
may increase your
EGGS
10
RISK
11
certain medical conditions.
MEATS, POULTRY,
illness, especially if you have
12
13
14
3-7
CONTAMINATED FOOD
Subpart
15
3-701
Disposition
3-701.11
Discarding
16
17
Disposition
18
19
or
Reconditioning
Unsafe,
Adulterated, or Contaminated Food.*
(A)
A
FOOD
that is unsafe,
presented
21
discarded or reconditioned according to an
22
procedure.
(B)
24
25
specified
FOOD that is not from an
under
or not
20
23
as
ADULTERATED,
§ 3-101.11 shall
APPROVED
be
APPROVED
source as specified
under §§ 3-201.11 - .17 shall be discarded.
(C)
READY-TO-EAT
FOOD
that may have been contaminated
26
by an
27
specified under § 2-201.12 shall be discarded.
28
honestly
(D)
EMPLOYEE
who has been
FOOD that is contaminated by
RESTRICTED
or
EXCLUDED as
FOOD EMPLOYEES, CONSUMERS,
29
or other
30
discharges, such as nasal or oral discharges, or other
PERSONS
106
through contact with their hands, bodily
1
04.05.11
means shall be discarded.
2
3
4
3-8
SPECIAL REQUIREMENTS FOR HIGHLY SUSCEPTIBLE POPULATIONS
Subpart
5
3-801
Additional Safeguards
3-801.11
Pasteurized Foods, Prohibited Re-Service, and
6
7
Additional
8
Safeguards
9
Prohibited Food*
In a FOOD ESTABLISHMENT that serves a HIGHLY SUSCEPTIBLE POPULATION:
10
11
12
(A)
The following criteria apply to
(1)
JUICE:
For the purposes of this paragraph only, children
13
who are age 9 or less and receive
14
school,
15
provides custodial care are included as
16
SUSCEPTIBLE POPULATIONS;
17
(2)
day
PrePACKAGED
care
JUICE
FOOD
in a
setting, or similar facility that
or a prePACKAGED
HIGHLY
BEVERAGE
18
containing
JUICE,
19
specified
in 21 CFR, 101.17(g) Food
20
warning,
21
Juices that have not been specifically processed
22
to prevent, reduce, or eliminate the presence of
23
pathogens, or a
24
containing
25
specified under ¶ 3-404.11(B) shall not be served
26
or offered for sale; and
27
(3)
that bears a warning label as
notice, and
JUICE,
UnPACKAGED
safe
handling
PACKAGED JUICE
that bears
JUICE
that
is
premises for service or sale in a
29
shall be processed under
30
contains
107
statements,
or
BEVERAGE
a warning label as
28
the information
labeling,
a
prepared
on
the
READY-TO-EAT form
HACCP
specified
PLAN
under
that
¶¶ 8-
1
04.05.11
201.14(B) - (E) and as specified in 21 CFR Part
2
120 – Hazard Analysis and Critical Control Point
3
(HACCP)
4
Reduction, 120.24 Process controls.
5
(B)
Pasteurized
6
for raw
7
(1)
Systems,
EGGS
EGGS
or
Subpart
EGG PRODUCTS
B
Pathogen
shall be substituted
in the preparation of:
FOODS such as Caesar
salad, hollandaise or
8
Béarnaise sauce, mayonnaise, meringue,
9
ice cream, and
10
(2)
EGG-fortified BEVERAGES,
in which more than one
12
EGGS
(C)
sale in a
15
(1)
FOODS
animal
16
marinated
17
tartare,
(2)
FISH,
20
made from raw
(D)
23
such
raw
FISH,
rare
MEAT,
EGGS,
(3)
Raw seed sprouts.
FOOD
EMPLOYEES
as
raw
FISH,
MOLLUSCAN SHELLFISH,
A partially cooked animal
cooked
22
form:
FOODS
19
21
is broken and the
shall not be served or offered for
READY-TO-EAT
Raw
EGG
are combined;
The following
14
18
and
Except as specified in ¶ (F) of this section, recipes
11
13
EGGnog,
FOOD
soft-cooked
raw-
and steak
such as lightly
EGGS
that are
and meringue; and
shall not contact
READY-TO-EAT FOOD
specified under ¶¶ 3-301.11(B) and (D).
24
(E)
Reserved.
25
(F)
Subparagraph (B)(2) of this section does not apply if:
26
as
(1)
The raw
EGGS
are combined immediately before
27
cooking for one
28
meal, cooked as specified under Subparagraph
29
3-401.11(A)(1), and served immediately,
30
an omelet, soufflé, or scrambled EGGS;
108
CONSUMER’S
serving at a single
such as
1
(2)
The raw
04.05.11
are combined as an ingredient
EGGS
2
immediately before
3
thoroughly cooked to a
4
as a cake, muffin, or bread; or
5
(3)
baking and the
EGGS
READY-TO-EAT
are
form, such
The preparation of the food is conducted under a
6
HACCP
7
(a)
Identifies the
8
(b)
Prohibits contacting READY-TO-EAT FOOD with bare
9
PLAN
that:
FOOD
to be prepared,
hands,
10
(c)
Includes specifications and practices that ensure:
11
12
(i)
13
Salmonella Enteritidis growth is controlled
before and after cooking, and
14
(ii) Salmonella
Enteritidis
15
cooking
EGGS
16
temperature
17
Subparagraph 3-401.11(A)(2),
18
(d)
19
the
and
is
destroyed by
according
time
to the
specified
in
Contains the information specified under ¶ 8201.14(D ) including procedures that:
20
(i)
Control cross contamination of
21
FOOD
22
(ii) Delineate
with raw
procedures
24
and
(e)
and
cleaning
23
25
EGGS,
for
and
27
preparation of the
28
procedures to be used.
30
Food
(G)
FOOD EMPLOYEE
responsible for the
FOOD
Except as specified in paragraph (H)
FOOD
SURFACES,
Describes the training program that ensures
that the
Re-service of
SANITIZATION
FOOD-CONTACT
26
29
READY-TO-EAT
understands the
of this section,
may be re-served as specified under Subparagraph
109
1
04.05.11
3-306.14(B)(1) and (2).
2
Prohibited
3
Re-service of
4
Food
(H)
FOOD shall not be re-served under the following conditions.
(1)
Any
FOOD
served to patients or clients who are
under contact precautions in medical isolation or
5
quarantine, or protective environment isolation shall
6
not be re-served to others outside.
7
(2)
Packages of
8
other
9
PERSONS
FOOD
CONSUMERS
from any patients, clients, or
should
not
be
re-served to
in protective environment isolation.
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
110
04.05.11
1
2
INTENTIONALLY LEFT BLANK
3
4
5
6
7
111
04.05.11
1
Chapter
2
4
3
Parts
4
4-1
MATERIALS FOR CONSTRUCTION AND REPAIR
5
4-2
DESIGN AND CONSTRUCTION
6
4-3
NUMBERS AND CAPACITIES
7
4-4
LOCATION AND INSTALLATION
8
4-5
MAINTENANCE AND OPERATION
9
4-6
CLEANING OF EQUIPMENT AND UTENSILS
10
4-7
SANITIZATION OF EQUIPMENT AND UTENSILS
11
4-8
LAUNDERING
12
4-9
PROTECTION OF CLEAN ITEMS
4-1
MATERIALS FOR CONSTRUCTION AND REPAIR
Equipment, Utensils, and Linens
13
14
15
Subparts
4-101
16
Multiuse
4-102
17
Single-Service and Single-Use
18
19
Multiuse
4-101.11
Characteristics.*
20
Materials that are used in the construction of
21
FOOD-CONTACT
22
migration of deleterious substances or impart colors, odors, or
23
tastes to
24
(A)
Safe;
25
(B)
Durable,
26
(C)
Sufficient in weight and thickness to withstand repeated
27
28
FOOD
SURFACES
EQUIPMENT
shall
not
allow the
and under normal use conditions shall be:
CORROSION-RESISTANT,
WAREWASHING;
(D)
of
and
UTENSILS
and nonabsorbent;N
N
Finished to have a
112
SMOOTH, EASILY CLEANABLE surface;
N
and
1
(E)
04.05.11
Resistant to pitting, chipping, crazing, scratching, scoring,
distortion, and decomposition.N
2
3
4-101.12
4
(A)
Cast Iron, Use Limitation.
Except
as specified in ¶¶ (B) and (C) of this section,
5
cast iron shall not
6
CONTACT SURFACES
of
be used
for
or
UTENSILS
FOOD-
EQUIPMENT.
7
B)
Cast iron may be used as a surface for cooking.
8
(C)
Cast iron may be used in
9
UTENSILS
10
UTENSILS
for serving
FOOD
if the
are used only as part of an uninterrupted
process from cooking through service.
11
4-101.13
12
(A)
Lead, Use Limitation.
Ceramic, china, and crystal UTENSILS, and decorative UTENSILS
13
such as hand painted ceramic or china that are used in
14
contact with
15
lead not
16
categories:
17
UTENSIL
18
Category
FOOD
shall be lead-free or contain levels of
exceeding the limits of the following
Ceramic
Article Description
Maximum Lead
MG/L
19
20
Beverage Mugs,
21
Cups, Pitchers
Coffee Mugs
0.5
22
23
Large Hollowware
Bowls > 1.1 Liter
24
(excluding pitchers)
(1.16 Quart)
Small Hollowware
Bowls < 1.1 Liter
1
25
26
27
(excluding cups & mugs)
2.0
(1.16 Quart)
28
29
Flat TABLEWARE
Plates, Saucers
30
113
UTENSIL
3.0
1
(B)
2
3
04.05.11
Pewter alloys containing lead in excess of 0.05% shall
not be used as a
(C)
Solder and flux containing lead in excess of 0.2% shall
not be used as a
4
FOOD-CONTACT SURFACE.
5
4-101.14
6
(A)
FOOD-CONTACT SURFACE.
Copper, Use Limitation.*
Except as specified in ¶ (B) of this section, copper and
7
copper
alloys such as brass shall
8
contact with a
9
vinegar,
fruit
not be used in
FOOD
that has a pH below 6 such as
JUICE,
or wine or for a fitting or tubing
10
installed between a backflow prevention device and a
11
carbonator.
12
(B)
Copper and copper alloys may be used in contact with
13
beer brewing ingredients that have a pH below 6 in the
14
prefermentation and fermentation steps of a beer brewing
15
operation such as a brewpub or microbrewery.
16
4-101.15
17
Galvanized metal shall not be used for
18
SURFACES
Galvanized Metal, Use Limitation.*
of
EQUIPMENT
UTENSILS
or
FOOD-CONTACT
that are used in contact with acidic
FOOD.
19
4-101.16
Sponges, Use Limitation.
20
Sponges shall not be used in contact with cleaned and
21
SANITIZED
22
4-101.17
23
(A)
or in-use
FOOD-CONTACT SURFACES.
Wood, Use Limitation.
Except as specified in ¶¶ (B), (C), and (D) of this section,
24
wood and wood wicker shall not be used as a
25
CONTACT SURFACE.
26
(B)
FOOD-
Hard maple or an equivalently hard, close-grained wood
27
may be used for:
28
(1)
Cutting boards; cutting blocks; bakers' tables; and
29
UTENSILS
30
salad bowls, and chopsticks; and
such as rolling pins, doughnut dowels,
114
1
(2)
04.05.11
Wooden paddles used in confectionery operations
2
for
3
preparing confections at a temperature of 110 oC
4
(230oF) or above.
5
(C)
pressure
scraping
kettles
when manually
Whole, uncut, raw fruits and vegetables, and nuts in the
6
shell may be kept in the wood shipping containers in
7
which they were received, until the fruits, vegetables, or
8
nuts are used.
9
(D)
If the nature of
the
FOOD
requires removal of rinds,
10
peels, husks, or shells before consumption, the whole,
11
uncut, raw
12
(1)
Untreated wood containers; or
13
(2)
Treated
FOOD
may be kept in:
wood
containers
14
treated
15
requirements
16
Preservatives for wood.
with a
if
the
containers are
preservative that meets the
specified
in
21
CFR
178.3800
17
4-101.18
Nonstick Coatings, Use Limitation.
18
Multiuse
19
pans, cookie sheets, and waffle bakers that have a perfluorocarbon
20
resin coating shall
KITCHENWARE
such as frying pans, griddles, sauce
be used with nonscoring or nonscratching
21
UTENSILS
and cleaning aids.
22
4-101.19
23
NonFOOD-CONTACT SURFACES of EQUIPMENT that are exposed to splash,
24
spillage, or other FOOD soiling or that require frequent cleaning shall
25
be constructed of a
26
SMOOTH
Nonfood-Contact Surfaces.
CORROSION-RESISTANT,
nonabsorbent,
and
material.
27
Single-Service
4-102.11
28
and Single-Use
Materials that are used to make
29
ARTICLES:
30
(A)
Characteristics.*
May not:
115
SINGLE-SERVICE
and
SINGLE-USE
1
(1)
04.05.11
Allow the migration of deleterious substances, or
2
(2)
Impart colors, odors, or tastes to
3
(B)
FOOD;
N
and
Shall be:
4
(1)
Safe, and
5
(2)
Clean.N
6
7
4-2
8
DESIGN AND CONSTRUCTION
Subparts
9
4-201
Durability and Strength
10
4-202
Cleanability
11
4-203
Accuracy
12
4-204
Functionality
13
4-205
Acceptability
Equipment and Utensils.
14
15
Durability and
4-201.11
16
Strength
EQUIPMENT and
UTENSILS
shall be designed and constructed to
17
be durable and to retain their characteristic qualities under
18
normal use conditions.
19
4-201.12
20
FOOD
21
stems constructed of glass, except that thermometers with glass
22
sensors or stems that are encased in a shatterproof coating
23
such as candy thermometers may be used.
24
25
Cleanability
TEMPERATURE MEASURING DEVICES
4-202.11
(A)
Food Temperature Measuring Devices.*
Food-Contact Surfaces.*
Multiuse
FOOD-CONTACT SURFACES
26
(1)
SMOOTH;
27
(2)
Free
28
29
30
shall not have sensors or
of
shall be:
breaks, open seams, cracks, chips,
inclusions, pits, and similar imperfections;
(3)
Free
of
sharp
crevices;
116
internal
angles,
corners,
and
1
(4)
Finished to have
2
(5)
Except
as
04.05.11
welds and joints; and
SMOOTH
specified
in ¶ (B)
of
this section,
3
accessible for cleaning and inspection by one of
4
the following methods:
5
(a)
Without being disassembled,
6
(b)
By disassembling without the use of tools,
7
or
8
(c)
9
By easy disassembling
handheld
tools
with the use of
commonly
available
to
10
maintenance and cleaning
11
as screwdrivers, pliers, open-end wrenches,
12
and Allen wrenches.
13
(B)
Subparagraph
(A)(5) of
this
personnel such
section does not apply to
14
cooking oil storage tanks, distribution lines for cooking
15
oils, or
syrup lines or tubes.
BEVERAGE
16
4-202.12
CIP Equipment.
17
(A)
EQUIPMENT
CIP
shall meet the characteristics specified
18
under § 4-202.11 and shall be designed and constructed
19
so that:
20
(1)
Cleaning
and
SANITIZING
solutions
circulate
21
throughout a fixed system and contact all interior
22
FOOD-CONTACT SURFACES,
23
(2)
The system is self-draining or capable of being
24
completely
25
solutions; and
26
(B)
CIP
and
EQUIPMENT
drained
of
cleaning
and
SANITIZING
that is not designed to be disassembled
27
for cleaning shall be designed with inspection access
28
points to ensure that all
interior
29
throughout
system are
30
cleaned.
the
117
fixed
FOOD-CONTACT SURFACES
being
effectively
04.05.11
1
4-202.13
“V” Threads, Use Limitation.
2
Except
3
threads shall not be used on
4
4-202.14
5
Hot
6
specified under
7
accessible for filter replacement and cleaning of the filter.
8
4-202.15
9
Cutting or piercing parts of can openers shall be readily
for hot oil cooking or filtering
oil
EQUIPMENT,
“V” type
FOOD-CONTACT SURFACES.
Hot Oil Filtering Equipment.
filtering
shall
EQUIPMENT
meet the characteristics
§ 4-202.11 or § 4-202.12 and shall be readily
Can Openers.
10
removable for cleaning and for replacement.
11
4-202.16
12
NonFOOD-CONTACT
13
ledges,
14
constructed
15
maintenance.
16
4-202.17
17
Kick plates shall be designed so that the areas behind them
18
are accessible for inspection and cleaning by being:
19
(A)
Nonfood-Contact Surfaces.
projections,
to
shall be free of unnecessary
SURFACES
and
allow
crevices,
easy
and
cleaning
designed
and
to
and
facilitate
Kick Plates, Removable.
Removable by one of the methods specified under
20
Subparagraph 4-202.11(A)(5) or capable of being rotated
21
open; and
22
(B)
23
Removable or capable of being rotated open without
unlocking
EQUIPMENT
doors.
24
4-202.18
25
Filters or other grease extracting
26
to be readily removable for cleaning and replacement if not
27
designed to be cleaned in place.
28
29
30
Accuracy
Ventilation Hood Systems, Filters.
EQUIPMENT
shall be designed
4-203.11
Temperature Measuring Devices, Food.
(A)
TEMPERATURE MEASURING DEVICES
FOOD
that are scaled only
in Celsius or dually scaled in Celsius and Fahrenheit
118
04.05.11
shall be accurate to ±1oC in the intended range of use.
1
2
(B)
FOOD
TEMPERATURE MEASURING DEVICES
that are scaled only
3
in Fahrenheit shall be accurate to ±2oF in the intended
4
range of use.
4-203.12
5
Temperature Measuring Devices, Ambient Air
and Water.
6
7
(A)
Ambient air and water TEMPERATURE
MEASURING DEVICES
that
8
are scaled in Celsius or dually scaled in Celsius and
9
Fahrenheit shall be designed to be easily readable and
accurate to ±1.5oC in the intended range of use.
10
11
(B)
Ambient air and water
TEMPERATURE MEASURING DEVICES that
12
are scaled only in Fahrenheit shall be accurate to ±3oF in
13
the intended range of use.
4-203.13
14
Pressure
Measuring
Devices,
Mechanical
Warewashing Equipment.
15
16
Pressure measuring devices that display the pressures in the
17
water supply line for the fresh hot water sanitizing rinse shall
18
have increments of 7 kilopascals (1 pound per square inch) or
19
smaller and shall be accurate to ±14 kilopascals (±2 pounds
20
per square inch) in the range indicated on the manufacturer's
21
data plate.
22
Functionality
4-204.11
Ventilation Hood Systems, Drip Prevention.
23
Exhaust ventilation hood systems in
24
WAREWASHING
25
fans, guards, and ducting shall be designed to prevent grease
26
or
27
EQUIPMENT, UTENSILS, LINENS,
28
ARTICLES.
29
4-204.12
30
(A)
FOOD
areas including components
condensation
from
draining
and
or
preparation and
such
dripping
SINGLE-SERVICE
as
onto
and
hoods,
FOOD,
SINGLE-USE
Equipment Openings, Closures and Deflectors.
A cover or lid for
119
EQUIPMENT
shall overlap the opening
1
2
04.05.11
and be sloped to drain.
(B)
An
opening
located
within the top of a unit of
3
EQUIPMENT
4
shall be flanged upward at least 5 millimeters (two-tenths
5
of an inch).
6
(C)
that is designed for use with a cover or lid
Except as specified under ¶ (D) of this section, fixed
7
piping,
8
other parts extending into
9
with a watertight joint at the point where the item enters
10
11
the
(D)
12
TEMPERATURE MEASURING DEVICES,
EQUIPMENT
rotary shafts, and
shall be provided
EQUIPMENT.
If a watertight joint is not provided:
(1)
The piping, TEMPERATURE
MEASURING DEVICES,
rotary
13
shafts,
14
openings
15
designed to deflect condensation, drips, and dust
16
from openings into the
17
(2)
18
19
and
other parts extending through the
shall
be
equipped
FOOD;
with
an
apron
and
The opening shall be flanged as specified under
¶ (B) of this section.
4-204.13
Dispensing Equipment, Protection of Equipment
and Food.
20
21
In
22
unPACKAGED form:
23
(A)
EQUIPMENT
that dispenses or vends liquid
FOOD
or ice in
The delivery tube, chute, orifice, and splash surfaces
24
directly above the container receiving the
25
designed in a manner, such as with barriers, baffles, or
26
drip aprons, so that drips from condensation and splash
27
are diverted from the opening of the container receiving
28
the
29
30
(B)
FOOD
shall be
FOOD;
The delivery tube, chute, and orifice shall be protected
from manual contact such as by being recessed;
120
1
(C)
The
04.05.11
delivery tube or chute and orifice of
EQUIPMENT
2
used to vend liquid
3
self-service
4
delivery tube or chute and
orifice are protected from
5
dust, insects, rodents, and
other
6
self-closing door if the
EQUIPMENT
7
(1)
outside
FOOD
CONSUMERS
Located
in
an
or ice in unPACKAGED form to
shall be designed
so that the
contamination by a
is:
area
that
does
not
8
otherwise afford the protection of an enclosure
9
against
the
rain,
windblown
debris,
insects,
10
rodents, and other contaminants that are present
11
in the environment, or
12
(2)
Available for self-service during hours when it is
13
not
14
EMPLOYEE;
15
(D)
The
under the full-time supervision of a
FOOD
and
dispensing
EQUIPMENT
actuating lever or mechanism
16
and filling device of
CONSUMER
self-service
17
dispensing
shall
designed
18
contact with the lip-contact surface of glasses or cups
19
that are refilled.
20
(E)
EQUIPMENT
Dispensing equipment
be
in which
BEVERAGE
to
potentially
prevent
hazardous
21
food (time/temperature control
22
homogenous liquid form is maintained outside of
23
temperature control requirements as specified under §3-
24
501.16(A) shall:
25
(1)
for
safety
food )
in
a
the
be specifically designed and equipped to maintain
26
the commercial
27
food in a homogenous liquid form for a specified
28
duration from the time of opening the packaging
29
within the equipment; and
30
(2)
sterility of aseptically packaged
conform to the requirements for this equipment as
121
1
04.05.11
specified in NSF/ANSI 18-2006- Manual Food and
2
Beverage Dispensing Equipment.
3
4-204.14
Vending Machine, Vending Stage Closure.
4
The dispensing compartment of a
5
machine
6
that is not
7
SAFETY FOOD)
8
be equipped with a self-closing door or cover if the machine is:
9
(A)
that
including a
VENDING MACHINE
is designed to vend prePACKAGED snack
POTENTIALLY HAZARDOUS
FOOD
(TIME/TEMPERATURE CONTROL FOR
such as chips, party mixes, and pretzels shall
Located in an outside area that does not
otherwise
10
afford the protection of an enclosure against the rain,
11
windblown
12
contaminants that are present in the environment; or
13
(B)
debris,
insects,
rodents,
other
Available for self-service during hours when it is not
under the full-time supervision of a
14
and
FOOD EMPLOYEE.
15
4-204.15
Bearings and Gear Boxes, Leak proof.
16
EQUIPMENT
containing
17
lubricants shall be designed
18
lubricant
19
FOOD-CONTACT SURFACES.
20
4-204.16
21
Except for cold plates that are constructed integrally with an
22
ice storage bin,
23
cooling devices shall not be installed in contact with stored
24
ice.
25
4-204.17
26
Liquid waste drain lines shall not pass through an ice machine
27
or ice storage bin.
28
4-204.18
29
If a condenser unit is an integral component of
30
condenser unit shall be separated from the
cannot
bearings
and
and
gears
that
require
constructed so that
leak, drip, or be forced into
FOOD
the
or onto
Beverage Tubing, Separation.
BEVERAGE
tubing and cold-plate
BEVERAGE
Ice Units, Separation of Drains.
Condenser Unit, Separation.
122
EQUIPMENT,
FOOD
and
the
FOOD
04.05.11
1
storage space by a dustproof barrier.
2
4-204.19
3
Cutting or piercing parts of can openers on
4
shall be protected from manual contact, dust, insects, rodents,
5
and other contamination.
6
4-204.110
7
(A)
Can Openers on Vending Machines.
VENDING MACHINES
Molluscan Shellfish Tanks.
Except
as
specified
under
¶ (B)
of
this
section,
8
MOLLUSCAN SHELLFISH
9
shall not be used to display shellfish that are offered for
10
human consumption and shall be conspicuously marked
11
so that it is obvious to the
12
are for display only.
13
(B)
MOLLUSCAN
SHELLFISH
life support system display tanks
CONSUMER
that the shellfish
life-support system display tanks that
14
are used to store and display shellfish that are offered for
15
human consumption shall be operated and maintained in
16
accordance with a
17
AUTHORITY
18
that:
19
(1)
20
21
VARIANCE
granted by the
as specified in § 8-103.10 and a HACCP
Is submitted by the
PERMIT HOLDER
and
PLAN
APPROVED as
specified under § 8-103.11; and
(2)
22
Ensures that:
(a)
Water used with
23
SHELLFISH
24
tank,
25
(b)
FISH
other than
The safety and quality of the shellfish as
they
27
by the use of the tank, and
28
(c)
29
MOLLUSCAN
does not flow into the molluscan
26
30
REGULATORY
were
received are not compromised
The identity of the source of the
SHELLSTOCK
is retained as specified under § 3-203.12.
4-204.111
Vending Machines, Automatic Shutoff.*
123
1
(A)
A
machine
04.05.11
vending
POTENTIALLY
HAZARDOUS
FOOD
2
(TIME/TEMPERATURE
3
automatic control that prevents the machine from vending
4
FOOD:
5
(1)
CONTROL FOR SAFETY FOOD)
shall have an
If there is a power failure, mechanical failure, or
6
other condition that results in an internal machine
7
temperature
8
temperatures as specified under Chapter 3; and
9
(2)
that
cannot
of
11
serviced and restocked with
12
maintained
13
Chapter 3.
(B)
FOOD
If a condition specified under Subparagraph (A)(1)
10
14
maintain
this
section
at
occurs, until
the
FOOD
temperatures
machine
is
that has been
specified
under
When the automatic shutoff within a machine vending
15
potentially
hazardous food (time/temperature control for
16
safety food) is activated:
17
(1)
In a refrigerated vending machine, the ambient air
18
temperature shall not exceed 5°C (41°F) for more
19
than 30 minutes immediately after the machine is
20
filled, serviced, or restocked; or
21
(2)
In a hot holding vending machine, the ambient air
22
temperature shall not be less than 57°C (135°F)
23
for more than 120 minutes immediately after the
24
machine is filled, serviced, or restocked.
25
4-204.112
26
(A)
Temperature Measuring Devices.
In a mechanically refrigerated or hot
FOOD
storage unit,
27
the sensor of a
28
located to measure the air temperature or a simulated
29
product temperature in the warmest part of a mechanically
30
refrigerated unit and in the coolest part of a hot
124
TEMPERATURE MEASURING DEVICE
shall be
FOOD
1
2
04.05.11
storage unit.
(B)
Except as specified in ¶ (C) of this section, cold or hot
3
holding
4
(TIME/TEMPERATURE
5
designed to include and shall be equipped with at least
6
one integral or permanently affixed
7
DEVICE
8
9
EQUIPMENT
used for
POTENTIALLY HAZARDOUS FOOD
CONTROL FOR SAFETY FOOD)
shall be
TEMPERATURE MEASURING
that is located to allow easy viewing of
the
device's temperature display.
(C)
Paragraph (B) of this section does not apply to
EQUIPMENT
10
for which the placement of a TEMPERATURE MEASURING DEVICE
11
is not a practical means for measuring the ambient air
12
surrounding the
13
use of the
14
cold plates, bainmaries, steam tables, insulated
15
transport containers, and salad bars.
16
(D)
17
18
FOOD
because of the design, type, and
EQUIPMENT,
such as cal rod units, heat lamps,
TEMPERATURE
MEASURING DEVICES
FOOD
shall be designed to be
easily readable.
(E)
FOOD TEMPERATURE MEASURING DEVICES and water TEMPERATURE
19
MEASURING DEVICES
20
a numerical scale, printed record, or digital readout in
21
increments no greater than 1oC or 2oF in the intended
22
range of use.
23
4-204.113
on
Warewashing
WAREWASHING
Machine,
machines shall have
Data
Plate Operating
Specifications.
24
25
A
26
accessible and readable data plate affixed to the machine by
27
the
28
operation specifications including the:
29
(A)
30
WAREWASHING
machine
manufacturer
Temperatures
that
shall
indicates
required
SANITIZING;
125
be
the
for
provided with an easily
machine’s design and
washing,
rinsing,
and
1
(B)
Pressure required for the fresh water
04.05.11
rinse
SANITIZING
2
unless the machine is designed to use only a pumped
3
SANITIZING
4
(C)
5
rinse; and
Convey or speed for convey or machines or cycle time
for stationary rack machines.
6
4-204.114
7
W AREWASHING machine
8
equipped with baffles, curtains, or other means to minimize
9
internal cross contamination of the solutions in wash and rinse
10
tanks.
11
4-204.115
Warewashing Machines, Internal Baffles.
wash
and
rinse tanks shall be
Warewashing Machines, Temperature Measuring
Devices.
12
13
A WAREWASHING machine shall be equipped with a
14
MEASURING DEVICE
15
(A)
In each wash and rinse tank; and
16
(B)
As the water enters the hot water
18
that indicates the temperature of the water:
manifold or in the chemical
17
4-204.116
TEMPERATURE
SANITIZING
SANITIZING
final rinse
solution tank.
Manual Warewashing Equipment, Heaters and
Baskets.
19
20
If hot water is used for
SANITIZATION
21
operations, the
compartment of the sink shall be:
22
(A)
SANITIZING
of maintaining water
24
77 C (171 F); and
o
(B)
Provided
27
water.
equipment
and
utensils
into
the hot
Warewashing Machines, Automatic Dispensing of
Detergents and Sanitizers.
29
30
a temperature not less than
with a rack or basket to allow complete
immersion of
4-204.117
at
o
26
28
WAREWASHING
Designed with an integral heating device that is capable
23
25
in manual
A
WAREWASHING
machine that is installed after adoption of this
126
04.05.11
shall be equipped to:
1
Code by the
REGULATORY AUTHORITY,
2
(A)
Automatically dispense detergents and
3
(B)
Incorporate a visual means to verify that detergents and
SANITIZERS
5
signal if the detergents and
6
to the respective washing and
4-204.118
8
(A)
9
and
are delivered or a visual or audible alarm to
4
7
SANITIZERS;
SANITIZERS
are not delivered
SANITIZING
cycles.
Warewashing Machines, Flow Pressure Device.
W AREWASHING machines that provide a fresh hot water
SANITIZING
rinse shall be equipped with a pressure gauge
10
or similar device such as a transducer that measures
11
and
12
immediately before entering
13
and
14
(B)
displays
the water pressure in the supply line
the
WAREWASHING
machine;
If the flow pressure measuring device is upstream of the
15
fresh hot water
16
shall be mounted in a 6.4 millimeter or one-fourth inch
17
Iron Pipe Size (IPS) valve.
18
(C)
SANITIZING
rinse control valve, the device
Paragraphs (A) and (B) of this section do not apply to a
19
machine
20
SANITIZING
that
uses
only
a
pumped
or
recirculated
rinse.
21
4-204.119
Warewashing Sinks and Drain boards, Self Draining.
22
Sinks and drain boards of
23
shall be self-draining.
24
4-204.120
25
EQUIPMENT compartments that are subject to accumulation of moisture
26
due to conditions such as condensation,
27
or water from melting ice shall be sloped to an outlet that
28
allows complete draining.
29
4-204.121
30
(A)
WAREWASHING
sinks and machines
Equipment Compartments, Drainage.
FOOD
or
BEVERAGE
drip,
Vending Machines, Liquid Waste Products.
VENDING
MACHINES
127
designed to store
BEVERAGES
that are
04.05.11
in containers made from paper products shall
1
PACKAGED
2
be equipped with diversion devices and retention pans
3
or drains for container leakage.
4
(B)
VENDING
MACHINES
5
shall be:
6
(1)
Provided
that dispense liquid
with
an
receptacle for
8
overflow, or other internal wastes; and
(2)
in
internally mounted
7
9
the
FOOD
collection
of
drip,
Equipped with an automatic shutoff
bulk
waste
spillage,
device
that
10
will place the machine out of operation before the
11
waste receptacle overflows.
12
(C)
Shutoff devices specified under Subparagraph (B)(2) of
13
this section shall prevent water or liquid
14
continuously running
15
control device in the water or liquid
16
waste accumulation that could lead to overflow of the
17
waste receptacle.
FOOD
if there is a failure of
FOOD
from
a flow
system or
18
4-204.122
Case Lot Handling Apparatuses, Moveability.
19
Apparatuses, such as dollies, pallets, racks, and skids used
20
to store
21
received from a supplier in a cased or overwrapped lot, shall
22
be designed to be moved by hand
23
available apparatuses such as hand trucks and forklifts.
24
4-204.123
25
(A)
and transport
large quantities of
or
PACKAGED FOODS
by conveniently
Vending Machine Doors and Openings.
VENDING
MACHINE
doors and access opening covers to FOOD
26
and container storage spaces shall be tight-fitting so
27
that the space along the entire interface between the
28
doors or covers and the cabinet of the machine, if the
29
doors or covers are in a closed position, is no greater
30
than 1.5 millimeters or one-sixteenth inch by:
128
1
(1)
Being
covered
with
04.05.11
screens,
or
louvers,
2
materials that
3
not greater than 1.5 millimeters or one-sixteenth
4
inch.
5
centimeters
6
requirement;
provide
an equivalent opening of
Screening of 12
(12
mesh
or more
to
1
mesh
inch)
to 2.5
meets
this
7
(2)
Being effectively gasketed;
8
(3)
Having interface surfaces that are at least 13
9
millimeters or one-half inch wide; or
10
(4)
Jambs or surfaces used to form an L-shaped entry
11
path to the interface.
12
(B)
VENDING
MACHINE
service
connection openings through
13
an exterior wall
of a machine shall be closed by
14
sealants,
or
15
are no larger than 1.5 millimeters or one-sixteenth inch.
16
Acceptability
4-205.10
clamps,
grommets so that the openings
Food Equipment, Certification and Classification.
17
FOOD
18
an American
19
certification program is deemed to comply with Parts 4-1 and
20
4-2 of this chapter.
21
4-3
22
EQUIPMENT
that is certified or classified for sanitation by
National
Standards
Institute (ANSI) accredited
NUMBERS AND CAPACITIES
Subparts
23
4-301
Equipment
24
4-302
Utensils, Temperature Measuring Devices, and
Testing Devices
25
26
27
Equipment
4-301.11
Cooling, Heating, and Holding Capacities.
28
EQUIPMENT for cooling and heating
29
hot
30
provide
FOOD,
shall
FOOD
be
FOOD,
and holding cold and
sufficient in number and capacity to
temperatures as specified under Chapter 3.
129
1
4-301.12
Warewashing,
04.05.11
Compartment
Sink
Requirements.
2
3
Manual
(A)
Except as specified in ¶ (C) of this section, a sink with
4
at least 3 compartments shall be provided for manually
5
washing, rinsing, and
6
(B)
Sink compartments
shall
be
large
7
accommodate immersion of the largest
8
UTENSILS.
9
WAREWASHING
If
10
EQUIPMENT
11
used.
12
(C)
or
UTENSILS.
enough
to
EQUIPMENT
and
UTENSILS
are too large for the
WAREWASHING
machine or alternative
EQUIPMENT
sink, a
and
SANITIZING EQUIPMENT
as specified in ¶ (C) of this section shall be
Alternative manual
WAREWASHING EQUIPMENT
may be used
13
when there are special cleaning needs or constraints
14
and
15
WAREWASHING EQUIPMENT
16
(1)
High-pressure detergent sprayers;
17
(2)
Low- or line-pressure spray detergent foamers;
18
(3)
Other task-specific cleaning
19
(4)
Brushes or other implements;
20
(5)
2-compartment sinks as specified under ¶¶ (D) and
21
use
is
APPROVED.
Alternative
manual
may include:
EQUIPMENT;
(E) of this section; or
22
(6)
23
24
its
Receptacles that substitute for the compartments
of a multicompartment sink.
(D)
Before a 2-compartment sink is used:
25
(1)
The
26
(2)
The
PERMIT HOLDER shall
PERMIT
HOLDER
have its use
shall limit the number of
27
KITCHENWARE
28
2-compartment sink, and shall limit
29
batch operations for cleaning
30
as between
130
APPROVED; and
items cleaned and
SANITIZED
in the
WAREWASHING
KITCHENWARE
cutting one type of
raw
MEAT
to
such
and
1
another
2
shall:
3
(a)
04.05.11
the end of a shift, and
or cleanup at
Make up the cleaning and
SANITIZING
4
immediately before
5
immediately after use, and
6
(b)
solutions
use and drain them
Use a detergent-SANITIZER
to
and
SANITIZE
7
apply the detergent-SANITIZER in accordance with
8
the manufacturer’s label instructions and as
9
specified under § 4-501.115, or
10
(c)
Use a hot water SANITIZATION immersion step as
11
12
specified under ¶ 4-603.16(C).
(E)
A 2-compartment sink shall not be used for
13
operations where cleaning and
14
for a continuous or intermittent flow of
15
TABLEWARE
in an ongoing
SANITIZING
WAREWASHING
WAREWASHING
solutions are used
KITCHENWARE
or
process.
16
4-301.13
17
Drain boards,
18
accommodate
19
accumulate during hours of operation shall be provided for
20
necessary
21
4-301.14
22
Ventilation hood systems and devices shall be sufficient in
23
number and capacity to prevent grease or condensation from
24
collecting on walls and ceilings.
25
4-301.15
26
(A)
Drain boards.
UTENSIL
all
UTENSIL
racks, or tables large
soiled
and
cleaned
enough
items
that
holding before cleaning and after
to
may
SANITIZING.
Ventilation Hood Systems, Adequacy.
Clothes Washers and Dryers.
Except
as specified in ¶ (B) of this section, if work
27
clothes or
28
mechanical clothes washer and dryer shall be provided
29
and used.
30
(B)
LINENS
are laundered on the
PREMISES,
a
If on-PREMISES laundering is limited to wiping cloths intended
131
1
04.05.11
used moist, or wiping cloths are air-dried as
to be
2
specified under § 4-901.12, a mechanical clothes washer
3
and dryer need not be provided.
4
Utensils,
4-302.11
5
Temperature
A
7
Measuring
container displayed at a
8
Devices,
buffet or salad bar.
9
and Testing
FOOD
Utensils, Consumer Self-Service.
dispensing
UTENSIL
shall
be
available for each
6
10
CONSUMER
self-service unit such as a
Devices
11
4-302.12
12
(A)
Food Temperature Measuring Devices.
FOOD
TEMPERATURE
13
provided
14
attainment and maintenance of
15
specified under Chapter 3.
16
(B)
A
and
MEASURING
DEVICES
shall
be
readily accessible for use in ensuring
TEMPERATURE MEASURING DEVICE
is
with a suitable small-
diameter
18
temperature
19
readily accessible to accurately measure the temperature
20
in thin
4-302.13
that
temperatures as
17
21
probe
FOOD
designed
to measure the
of thin masses shall be provided
FOODS
such as
Temperature
MEAT
patties and
Measuring
FISH
Devices,
and
filets.
Manual
Warewashing.
22
23
In manual WAREWASHING operations, a TEMPERATURE MEASURING DEVICE
24
shall be provided and readily accessible for frequently measuring the
25
washing and
26
4-302.14
27
A
28
concentration
29
provided.
SANITIZING
temperatures.
Sanitizing Solutions, Testing Devices.
test kit or other device that
in
MG/L
30
132
of
accurately measures the
SANITIZING
solutions
shall
be
04.05.11
1
4-4
2
LOCATION AND INSTALLATION
Subparts
3
4-401
Location
4
4-402
Installation
4-401.11
Equipment, Clothes Washers and Dryers, and
5
6
Location
Storage Cabinets, Contamination Prevention.
7
8
(A)
9
Except as specified in ¶ (B) of this section,
cabinet used for the storage of
FOOD,
EQUIPMENT,
a
or a cabinet that
10
is used to store cleaned and SANITIZED EQUIPMENT, UTENSILS,
11
laundered
LINENS,
and
SINGLE-SERVICE
12
ARTICLES
13
(1)
In locker rooms;
14
(2)
In toilet rooms;
15
(3)
In garbage rooms;
16
(4)
In mechanical rooms;
17
(5)
Under
18
and
SINGLE-USE
shall not be located:
sewer
lines
that
are
not
shielded
to
intercept potential drips;
19
(6)
Under
leaking
water
lines
including
leaking
20
automatic fire sprinkler heads or under lines on
21
which water has condensed;
22
(7)
Under open stairwells; or
23
(8)
Under other sources of contamination.
24
(B)
25
26
A storage cabinet used for LINENS or SINGLE-SERVICE or SINGLEUSE ARTICLES
(C)
may be stored in a locker room.
If a mechanical clothes washer or dryer is provided, it
27
shall be located so that
28
protected from contamination and only where there is no
29
exposed
30
and unwrapped
FOOD;
clean
the
EQUIPMENT, UTENSILS,
SINGLE-SERVICE
133
washer
and
or dryer is
and
LINENS;
SINGLE-USE ARTICLES.
04.05.11
1
2
Installation
4-402.11
(A)
Fixed Equipment, Spacing or Sealing.
EQUIPMENT that is fixed because it is not
3
shall be installed so that it is:
4
(1)
5
Spaced to allow access for cleaning along the
sides, behind, and above the
6
(2)
EASILY MOVABLE
Spaced
from
adjoining
EQUIPMENT;
EQUIPMENT,
walls,
and
7
ceilings a distance of not more than 1 millimeter
8
or one thirty-second inch; or
9
(3)
10
11
SEALED to adjoining EQUIPMENT or walls, if the EQUIPMENT
is exposed to spillage or seepage.
(B)
COUNTER-MOUNTED
EQUIPMENT
that is not
EASILY MOVABLE
12
shall be installed to allow cleaning of the
13
areas underneath and around the
14
(1)
SEALED; or
15
(2)
Elevated on legs as specified under ¶ 4-402.12(D).
16
4-402.12
17
(A)
EQUIPMENT
EQUIPMENT
and
by being:
Fixed Equipment, Elevation or Sealing.
Except as specified in ¶¶ (B) and (C) of this section,
18
floor-mounted
19
be
20
at least a 15 centimeter (6 inch) clearance between the
21
floor and the
22
(B)
SEALED
EQUIPMENT
that is not
EASILY MOVABLE
shall
to the floor or elevated on legs that provide
EQUIPMENT.
If no part of the floor under the floor-mounted
EQUIPMENT
23
is more than 15 centimeters (6 inches) from the point of
24
cleaning access, the clearance space may be only 10
25
centimeters (4 inches).
26
(C)
This section does not apply to display shelving units, display
27
refrigeration units, and display freezer units located in the
28
CONSUMER
29
floor under the units is maintained clean.
30
(D)
shopping areas of a retail
FOOD
store, if the
Except as specified in ¶ (E) of this section,
134
COUNTER-
MOUNTED EQUIPMENT
2
elevated on legs that provide at least a 10 centimeter (4
3
inch) clearance between the table and the
4
(E)
The
that is not
04.05.11
shall be
1
EASILY MOVABLE
EQUIPMENT.
clearance space between the table and
5
MOUNTED EQUIPMENT
6
(1)
7.5
COUNTER-
may be:
centimeters
(3 inches)
if
the
horizontal
7
distance of the table top under the
8
more than 50 centimeters (20 inches) from the
9
point of access for cleaning; or
10
(2)
EQUIPMENT
is no
5 centimeters (2 inches) if the horizontal distance
11
of the table top under the
12
than 7.5 centimeters (3 inches ) from the point of
13
access for cleaning.
EQUIPMENT
is no more
14
15
4-5
16
MAINTENANCE AND OPERATION
Subparts
17
4-501
Equipment
18
4-502
Utensils and Temperature and Pressure
Measuring Devices
19
20
21
22
Equipment
4-501.11
(A)
Good Repair and Proper Adjustment.
EQUIPMENT
shall be maintained in a state of repair and
23
condition that
24
Parts 4-1 and 4-2.
25
(B)
meets the requirements specified under
EQUIPMENT components such as doors, seals, hinges,
26
fasteners, and kick plates shall be kept intact, tight, and
27
adjusted
28
specifications.
in
accordance
135
with
manufacturer's
1
04.05.11
Cutting or piercing parts of can openers shall be kept
(C)
2
sharp to minimize the creation of metal fragments that
3
can contaminate
FOOD
when the container is opened.
4
4-501.12
5
Surfaces
6
subject to scratching and scoring shall be resurfaced if they
7
can
8
discarded if they are not capable of being resurfaced.
9
4-501.13
no
Cutting Surfaces.
such
as
longer
cutting
be
blocks
and
boards
effectively cleaned and
that
are
SANITIZED,
or
Microwave Ovens.
10
Microwave ovens shall meet the safety standards specified in
11
21 CFR 1030.10 Microwave ovens.
12
4-501.14
13
A
14
or other receptacles used for washing and rinsing
Warewashing Equipment, Cleaning Frequency.
WAREWASHING
machine; the compartments of sinks, basins,
15
UTENSILS,
16
boards or other
17
as specified under § 4-301.13 shall be cleaned:
18
(A)
19
(B)
or raw
FOODS,
or laundering wiping cloths; and drain
EQUIPMENT
used to substitute for drain boards
Before use;
Throughout
the day at
a
20
prevent recontamination of
21
to ensure
22
function; and
23
(C)
24
4-501.15
that the
frequency necessary to
EQUIPMENT
EQUIPMENT
and
UTENSILS
and
performs its intended
If used, at least every 24 hours.
Warewashing
Machines,
Manufacturers'
Operating Instructions.
25
26
EQUIPMENT,
(A)
A
WAREWASHING
machine and its auxiliary components
27
shall be operated in accordance with the machine's data
28
plate and other manufacturer's instructions.
29
30
(B)
A
WAREWASHING
cycle
machine's conveyor speed or automatic
times shall be maintained accurately timed in
136
1
2
4-501.16
3
(A)
A
4
5
04.05.11
accordance with manufacturer's specifications.
Warewashing Sinks, Use Limitation.
WAREWASHING
sink shall not be used for handwashing
as specified under § 2-301.15.
(B)
If a
WAREWASHING
sink is used to wash wiping cloths,
6
wash produce, or thaw
7
as specified under § 4-501.14
8
time it is used to wash wiping cloths or wash produce
9
or thaw
FOOD.
FOOD,
the sink shall be cleaned
before
and after each
Sinks used to wash or thaw
10
be
11
after using the sink to wash produce or thaw
SANITIZED
as specified
under
Part 4-7
shall
FOOD
before and
FOOD.
12
4-501.17
Warewashing Equipment, Cleaning Agents.
13
When used for
14
mechanical
15
manual
16
shall
17
cleaner, alkaline cleaner, degreaser, abrasive cleaner, or other
18
cleaning agent according to the cleaning agent manufacturer's
19
label instructions.
20
4-501.18
21
The wash, rinse, and
22
clean.
23
4-501.19
WAREWASHING,
warewasher,
the wash compartment of a sink,
or wash receptacle of alternative
WAREWASHING EQUIPMENT
as specified in ¶ 4-301.12(C),
contain a wash solution
of
soap, detergent,
Warewashing Equipment, Clean Solutions.
SANITIZE
solutions shall be maintained
Manual Warewashing Equipment, Wash Solution
Temperature.
24
25
The temperature of the wash solution in manual
26
EQUIPMENT
27
or
28
manufacturer's label instructions.
29
4-501.110
30
acid
WAREWASHING
shall be maintained at not less than 43oC (110oF)
the temperature
Mechanical
specified
on
Warewashing
Solution Temperature.
137
the
cleaning
agent
Equipment,
Wash
1
A)
04.05.11
The temperature of the wash solution in spray type
2
warewashers that use hot water to
3
be less than:
4
(1)
6
(2)
For a stationary rack, single temperature machine,
For a stationary rack, dual temperature machine,
66oC (150oF);
7
8
(3)
For a single tank, conveyor, dual
temperature
machine, 71oC (160oF); or
9
10
(4)
For
a
multitank,
conveyor,
multitemperature
machine, 66oC (150oF).
11
(B)
The temperature of the wash solution in spray-type
13
warewashers that use chemicals to
14
be less than 49oC (120oF).
15
shall not
74oC (165oF);
5
12
SANITIZE
4-501.111 Manual
SANITIZE
shall not
Warewashing Equipment, Hot
Water
Sanitization Temperatures.*
16
17
If immersion in hot water is used for
18
operation, the temperature of the water shall be maintained
19
at 77oC (171oF) or above.
20
4-501.112
Mechanical Warewashing Equipment, Hot Water
Sanitization Temperatures.
21
22
in a manual
SANITIZING
(A)
Except
as
specified
in
¶(B)
of
this
section,
in a
23
mechanical operation, the temperature of the fresh hot
24
water
25
be more than 90oC, (194oF), or less than:
26
(1)
28
30
rinse as it enters the manifold shall not
For a stationary rack, single temperature machine,
74oC (165oF); or
27
29
SANITIZING
(2)
(B)
For all other machines, 82oC (180oF).
The maximum temperature specified under ¶ (A) of this
section,
does
not
138
apply
to the high pressure and
1
04.05.11
temperature systems with wand-type, hand-held, spraying
2
devices used
3
EQUIPMENT
4
4-501.113
for the in-place cleaning and
SANITIZING
of
such as meat saws.
Mechanical Warewashing Equipment, Sanitization
Pressure.
5
6
The flow pressure of the fresh hot water
7
WAREWASHING machine,
8
downstream or upstream from the fresh hot water
9
control value,
SANITIZING
rinse in a
as measured in the water line immediately
SANITIZING
rinse
shall be within the range specified on the
10
machine manufacturer's data plate and shall not be less than
11
35 kilopascals (5 pounds per square inch) or more than 200
12
kilopascals (30 pounds per square inch).
13
4-501.114
Manual and Mechanical Warewashing Equipment,
14
Chemical
15
Concentration, and Hardness.*
chemical
Sanitization
in
a
Temperature,
pH,
16
A
17
manual or mechanical
18
under ¶ 4-703.11(C)
19
§ 7-204.11 Sanitizers, Criteria, shall be used in accordance
20
with the EPA-approved
21
and shall be used as follows:
22
(A)
SANITIZER
used
-
SANITZING
solution for a
operation at exposure times specified
shall meet the criteria specified under
manufacturer's label use instructions,
A chlorine solution shall have a minimum temperature
23
based on the concentration and
24
listed in the following chart;
PH
of the solution as
25
26
Minimum
Minimum Temperature
27
Concentration
28
29
MG/L
30
PH
10 or less
PH
o
o
o
C ( F)
139
8 or less
C (oF)
04.05.11
1
2
25
49 (120)
49 (120)
3
50
38 (100)
24 ( 75)
4
100
13 ( 55)
13 ( 55)
5
6
(B)
An iodine solution shall have a:
7
(1)
Minimum temperature of 24oC (75oF),
8
(2)
PH
9
PH
no higher than the
level for which the manufacturer specifies the solution
10
is effective, and
11
12
of 5.0 or less or a
(3)
(C)
Concentration between 12.5 MG/L and 25 MG/L;
A quaternary ammonium compound solution shall:
13
(1)
Have a minimum temperature of 24oC (75oF),
14
(2)
Have
a
concentration
as
specified
under
§
15
7-204.11 and as indicated by the manufacturer's
16
use directions included in the labeling, and
17
(3)
Be used only in water with 500 MG/L hardness or
18
less or
19
than specified by the manufacturer's label;
20
(D)
If
another
in water having a hardness no greater
solution
of
a
chemical
21
¶¶ (A) (C) of this section is used, the
22
demonstrate to the
23
achieves
24
25
be
(E)
APPROVED;
If a chemical
under
PERMIT HOLDER
REGULATORY AUTHORITY
SANITIZATION
specified
shall
that the solution
and the use of the solution shall
or
SANITIZER
other than chlorine, iodine, or a
26
quaternary ammonium compound is used, it shall be
27
applied
28
directions included in the labeling.
29
30
4-501.115
in accordance
Manual
with
Warewashing
the
manufacturer’s
Equipment,
Sanitization Using Detergent-Sanitizers.
140
use
Chemical
1
If a detergent-SANITIZER is used to
2
SANITIZING
3
between the washing and
4
in the
5
is used in the washing step.
6
4-501.116
procedure
SANITIZING
where
SANITIZE
there
is
SANITIZING
04.05.11
in a cleaning and
no distinct water rinse
steps, the agent applied
step shall be the same detergent-SANITIZER that
Warewashing Equipment, Determining
Chemical Sanitizer Concentration.
7
8
Concentration of the
9
determined by using a test kit or other device.
4-502.11
SANITIZING
solution shall be accurately
Good Repair and Calibration.
10
Utensils and
11
Temperature
12
and Pressure
condition that
13
Measuring
under Parts 4-1 and 4-2 or shall be discarded.
14
Devices
(A)
(B)
UTENSILS shall be maintained in a state of repair or
FOOD
complies with the requirements specified
TEMPERATURE MEASURING DEVICES
shall be calibrated in
15
accordance with manufacturer's specifications as necessary
16
to ensure their accuracy.
17
(C)
Ambient air temperature, water pressure, and water
18
TEMPERATURE MEASURING DEVICES
19
good
20
range of use.
21
4-502.12
repair
and
be
shall be maintained in
accurate
within
the intended
Single-Service and Single-Use Articles, Required
Use.*
22
23
A
24
4-6
25
TABLEWARE
26
SERVICE ARTICLES, and SINGLE-USE ARTICLES for use by FOOD EMPLOYEES
27
28
FOOD
and 4-7
for
without facilities specified under Parts
cleaning
shall provide only
AND SINGLE-SERVICE ARTICLES
4-502.13
and
SANITIZING KITCHENWARE
and
SINGLE-USE KITCHENWARE, SINGLE-
for use by
CONSUMERS.
Single-Service and Single-Use Articles, Use
Limitation.
29
30
ESTABLISHMENT
(A)
SINGLE-SERVICE and
141
SINGLE-USE ARTICLES
shall
not
be
1
04.05.11
reused.
2
(B)
The bulk milk container dispensing tube shall be cut
3
on
the
diagonal
leaving
4
protruding from the chilled dispensing head.
5
4-502.14
6
Mollusk
7
once as serving containers.
no
more
than
one
inch
Shells, Use Limitation.
and
crustacea shells shall not be used more than
8
9
4-6
10
CLEANING OF EQUIPMENT AND UTENSILS
Subparts
11
4-601
Objective
12
4-602
Frequency
13
4-603
Methods
4-601.11
Equipment,
14
15
Objective
Food-Contact
17
(A)
18
EQUIPMENT
FOOD-CONTACT SURFACES
(B)
The
FOOD-CONTACT SURFACES
20
pans shall be kept free of
21
and other soil accumulations.N
22
(C)
23
UTENSILS
NonFOOD-CONTACT
SURFACES
of cooking
shall be
other debris.
Frequency
4-602.11
EQUIPMENT
and
encrusted grease deposits
of
EQUIPMENT
free of an accumulation of dust, dirt,
24
shall be kept
FOOD
residue, and
N
Equipment
Food-Contact
Surfaces
and
Utensils.*
26
(A)
EQUIPMENT
28
cleaned:
29
(1)
30
and
clean to sight and touch.
19
27
Nonfood-
Contact Surfaces, and Utensils.*
16
25
Surfaces,
FOOD-CONTACT SURFACES
and
UTENSILS
shall be
Except as specified in ¶ (B) of this section, before
each use with a different type of raw animal
142
FOOD
1
such as beef,
2
(2)
Each
3
raw
4
(3)
FISH,
FOODS
to working with
Between uses
with raw
and
6
(TIME/TEMPERATURE
(4)
DEVICE;
(5)
At
10
11
with
READY-TO-EAT FOODS;
fruits
POTENTIALLY
vegetables
HAZARDOUS
FOOD
CONTROL FOR SAFETY FOOD);
and
any time
during
the
operation
when
contamination may have occurred.
(B)
Subparagraph (A)(1) of this section does not apply if the
12
FOOD-CONTACT SURFACE
13
succession of different raw animal
14
a
higher
cooking
15
§3-401.11
16
raw
17
cutting board.
18
and
Before using or storing a FOOD TEMPERATURE MEASURING
8
9
04.05.11
POULTRY;
time there is a change from working with
5
7
lamb, pork, or
(C)
FISH
or
is in contact with a
UTENSIL
temperature
than the previous
FOODS
each requiring
as specified
FOOD,
under
such as preparing
followed by cutting raw poultry on the same
Except as specified in ¶ (D) of this section, if used with
19
POTENTIALLY HAZARDOUS FOOD
20
FOR SAFETY FOOD), EQUIPMENT FOOD-CONTACT SURFACES
21
UTENSILS
22
23
(TIME/TEMPERATURE
CONTROL
and
shall be cleaned throughout the day at least
every 4 hours.
(D)
Surfaces of
24
HAZARDOUS
25
FOOD)
26
if:
27
(1)
UTENSILS
and
EQUIPMENT
contacting
POTENTIALLY
FOOD (TIME/TEMPERATURE CONTROL FOR SAFETY
may be cleaned less frequently than every 4 hours
In storage, containers of
POTENTIALLY HAZARDOUS
28
FOOD (TIME/TEMPERATURE CONTROL FOR SAFETY FOOD) and
29
their contents are maintained at temperatures specified
30
under
Chapter 3 and the containers are cleaned
143
04.05.11
1
when they are empty;
2
(2)
UTENSILS and
EQUIPMENT
are used to prepare
FOOD
3
in a refrigerated room or area that is maintained at
4
one of the temperatures in the following chart and:
5
6
(a)
The
UTENSILS
and
EQUIPMENT
are cleaned at
7
the frequency
8
corresponds to the temperature; and
in
the
following chart
that
9
10
Temperature
Cleaning
Frequency
11
12
13
5.0oC (41oF) or less
24 hours
14
>5.0oC - 7.2oC
20 hours
o
o
15
(>41 F - 45 F)
16
>7.2oC - 10.0oC
17
(>45 F - 50 F)
18
>10.0oC - 12.8oC
19
(>50oF - 55oF)
o
16 hours
o
10 hours
20
21
22
(b)
The
cleaning
frequency
based
on
the
23
ambient temperature of the refrigerated room
24
or area is documented
25
ESTABLISHMENT.
26
(3)
Containers in serving
in
the
situations such as salad
27
bars, delis, and cafeteria lines hold
28
POTENTIALLY
29
CONTROL FOR SAFETY FOOD)
30
the temperatures specified under
144
HAZARDOUS
FOOD
FOOD
READY-TO-EAT
(TIME/TEMPERATURE
that
is maintained at
Chapter 3, are
1
04.05.11
intermittently combined with additional supplies of
2
the same
3
and the containers are cleaned at least every 24
4
hours;
5
(4)
FOOD
TEMPERATURE
that is at the required temperature,
MEASURING DEVICES
6
contact with
7
of deli
8
specified under Chapter 3;
9
(5)
EQUIPMENT is used for storage of
unpackaged
11
and
12
necessary
13
residues;
(6)
such as when left in a container
or in a roast, held at temperatures
FOOD
10
14
FOOD,
are maintained in
the
FOOD
such as a reach-in refrigerator
EQUIPMENT
to
is cleaned at a frequency
preclude
accumulation
The cleaning schedule is
15
consideration of:
16
(a)
Characteristics of the
17
(b)
The type of
18
(c)
The amount of
19
or
PACKAGED
FOOD
soil
based on
APPROVED
EQUIPMENT
of
and its use,
involved,
FOOD
residue accumulation,
and
20
(d)
The
temperature at which the
FOOD
is
21
maintained during the operation and the potential
22
for the rapid and progressive multiplication of
23
pathogenic or toxigenic microorganisms that are
24
capable of causing foodborne disease; or
25
(7)
In-use
UTENSILS
are
intermittently
stored in a
26
container of water in which the water is maintained
27
at
28
container are cleaned at least every 24 hours
29
or
30
accumulation of soil residues.
57oC (135oF) or more and the
at
a
145
frequency
necessary
UTENSILS
to
and
preclude
1
(E)
Except
when
dry
04.05.11
methods are used as
cleaning
2
specified under § 4-603.11, surfaces of
3
EQUIPMENT
4
(TIME/TEMPERATURE
5
cleaned:N
6
(1)
7
At
contacting
any
FOOD
that is not POTENTIALLY HAZARDOUS
CONTROL FOR SAFETY FOOD)
time
and
UTENSILS
when
contamination
shall
may
be
have
occurred;
8
(2)
At least every 24 hours for iced tea dispensers
and
9
10
self-service
CONSUMER
UTENSILS
such
as
tongs, scoops, or ladles;
11
(3)
Before restocking CONSUMER self-service EQUIPMENT and
12
UTENSILS
13
containers; and
14
(4)
In
such as condiment dispensers and display
such as ice bins and
EQUIPMENT
BEVERAGE
15
dispensing nozzles and enclosed components of
16
EQUIPMENT
17
tanks and distribution lines,
18
dispensing lines or tubes, coffee bean grinders,
19
and water vending
20
(a)
21
such as ice makers, cooking oil storage
At
a
BEVERAGE
and syrup
EQUIPMENT:
frequency
specified
by
the
manufacturer, or
22
(b)
Absent
manufacturer
necessary
specifications,
23
frequency
to
24
accumulation of soil or mold.
25
4-602.12
Cooking and Baking Equipment.
26
(A)
FOOD-CONTACT SURFACES
The
shall
be cleaned
at
a
preclude
of cooking and baking
27
EQUIPMENT
at least every 24 hours.
28
This section does not apply to hot oil cooking and
29
filtering
30
4-602.11(D)(6).
EQUIPMENT if it is cleaned as specified in Subparagraph
146
1
(B)
04.05.11
The cavities and door seals of microwave ovens shall
2
be cleaned
3
manufacturer's recommended cleaning procedure.
at
least
every
24
hours
by using the
4
4-602.13
5
NonFOOD-CONTACT
6
frequency necessary to preclude accumulation of soil residues.
7
8
Methods
Nonfood-Contact Surfaces.
4-603.11
(A)
9
If
SURFACES
of
used,
dry
cleaning
scraping, and
11
POTENTIALLY HAZARDOUS
12
SAFETY FOOD).
14
methods
dry
FOOD
SURFACES
residues that are not
(TIME/TEMPERATURE
CONTROL
SURFACES
may not be used for any other purpose.
16
(A)
used in dry cleaning
FOOD
debris
on
EQUIPMENT
scrapped
over
a
waste
18
receptacle
or
shall
be
19
machine with a prewash cycle.
If
FOR
FOOD-CONTACT
Precleaning.
17
necessary
for
21
EQUIPMENT
22
with abrasives.
23
brushing,
EQUIPMENT
4-603.12
(B)
as
Cleaning
15
20
such
vacuuming shall contact only
that are soiled with
(B)
shall be cleaned at a
Dry Cleaning.
10
13
EQUIPMENT
4-603.13
and
UTENSILS
disposal
unit
removed in a
effective
cleaning,
or
shall
be
garbage
WAREWASHING
UTENSILS
and
shall be preflushed, presoaked, or scrubbed
Loading
of
Soiled
Items,
Warewashing
Machines.
24
25
Soiled items to be cleaned in a
26
loaded into racks, trays, or baskets or onto conveyors in a
27
position that:
28
(A)
29
cycles; and
30
(B)
WAREWASHING
machine shall be
Exposes the items to the unobstructed spray from all
Allows the items to drain.
147
04.05.11
1
4-603.14
2
(A)
Wet Cleaning.
EQUIPMENT
FOOD-CONTACT SURFACES
and
UTENSILS
shall be
3
effectively washed to remove or completely loosen soils
4
by using the manual or mechanical means necessary
5
such as the application of detergents containing wetting
6
agent
7
cleaners; hot
8
pressure sprays; or ultrasonic devices.
9
(B)
and
emulsifiers;
water;
acid,
alkaline,
abrasive
brushes; scouring pads;
high-
The washing procedures selected shall be based on
10
the type and purpose of the
11
and on the type of soil to be removed.
12
or
4-603.15
Washing,
Procedures
or
UTENSIL,
Alternative
Manual
EQUIPMENT
for
Warewashing Equipment.
13
14
If washing in sink compartments or a
15
impractical such as when the
16
UTENSILS
17
alternative manual
18
4-301.12(C) in accordance with the following procedures:
19
(A)
20
21
EQUIPMENT
are too large, washing
is fixed or
the
as specified in ¶
EQUIPMENT shall be disassembled as necessary to allow
access of the detergent solution to all parts;
(B)
EQUIPMENT components and
or rough cleaned to remove
23
and
25
machine is
shall be done by using
WAREWASHING EQUIPMENT
22
24
WAREWASHING
(C)
EQUIPMENT and
UTENSILS
UTENSILS
FOOD
shall be scrapped
particle accumulation;
shall be washed as specified
under ¶ 4-603.14(A).
26
4-603.16
Rinsing Procedures.
27
Washed
28
abrasives are removed and cleaning chemicals are removed
29
or diluted through the use of water or a detergent-sanitizer
30
solution by using one of the following procedures:
UTENSILS
and
148
EQUIPMENT
shall
be
rinsed
so that
1
(A)
04.05.11
Use of a distinct, separate water rinse after washing and
2
before
3
(1)
A 3-compartment sink,
4
(2)
Alternative
SANITIZING
if using:
manual
WAREWASHING
EQUIPMENT
5
equivalent to a 3-compartment sink as specified
6
in ¶ 4-301.12(C), or
7
(3)
A
3-step
8
procedure
9
EQUIPMENT;
10
(B)
Use
of
a
washing,
in
a
rinsing,
§ 4-501.115 if using:
12
(1)
Alternative
WAREWASHING EQUIPMENT
¶ 4-301.12(C) that is
14
detergent-sANITIZER, or
16
(C)
17
WAREWASHING
APPROVED
system for
hot water
SANITIZATION
as specified in
for use with a
CIP EQUIPMENT;
immersion step of a 2-compartment
sink operation;
(D)
If using a
WAREWASHING
machine that does not recycle
20
the
21
section, or alternative manual
22
SANITIZING
solution as specified under ¶ (E) of this
WAREWASHING EQUIPMENT such
as sprayers, use of a nondistinct water rinse that is:
23
(1)
24
Integrated
in
the
application
of the
SANITIZING
solution, and
25
26
CIP
Use of a nondistinct water rinse that is integrated in the
18
19
A
system for
WAREWASHING
13
(2)
SANITIZING
detergent-SANITIZER as specified under
11
15
and
(2)
(E)
If
Wasted immediately after each application; or
using
a
WAREWASHING
machine
that recycles the
27
SANITIZING
28
of a nondistinct water rinse that is integrated in the
29
application of the
30
4-603.17
solution for use in the next wash cycle, use
SANITIZING
solution.
Returnables, Cleaning for Refilling.*
149
1
(A)
04.05.11
Except as specified in ¶¶ (B) and (C) of this section,
2
returned
3
refilling
4
regulated
5
(B)
A
empty containers intended for cleaning and
with
at a
7
(1)
be cleaned and refilled in a
FOOD PROCESSING PLANT.
FOOD-specific
6
shall
FOOD
container for
FOOD ESTABLISHMENT
Only a
BEVERAGE
may be refilled
BEVERAGES
if:
that is not a POTENTIALLY HAZARDOUS
8
FOOD (TIME/TEMPERATURE CONTROL FOR SAFETY FOOD)
9
used as specified under ¶ 3-304.17(A);
10
(2)
is
The design of the container and of the rinsing
11
EQUIPMENT
12
considered together, allow effective cleaning at
13
home or in the
14
(3)
and the nature of the
for
15
containers
with fresh,
16
pressure
17
part of the dispensing system;
18
(4)
The
rinsing
not
before refilling returned
hot
CONSUMER-owned
20
service only to the same
CONSUMER;
An EMPLOYEE of the
23
(b)
The owner of the container if
FOOD ESTABLISHMENT,
24
system
25
transfer process
26
by the container owner.
28
includes
a
4-7
VENDING MACHINE
SANITIZATION OF EQUIPMENT AND UTENSILS
150
BEVERAGE
contamination-free
CONSUMER-owned containers that are not
be filled at a water
the
or
that cannot be bypassed
29
30
and
The container is refilled by:
(a)
(C)
is under
for refilling is refilled for sale or
22
27
that
container returned to the
FOOD ESTABLISHMENT
(5)
water
recirculated are provided as
19
21
when
FOOD ESTABLISHMENT;
Facilities
and
BEVERAGE,
FOOD-specific may
or system.
04.05.11
1
Subparts
2
4-701
Objective
3
4-702
Frequency
4
4-703
Methods
4-701.10
Food-Contact Surfaces and Utensils.
5
6
Objective
7
8
EQUIPMENT FOOD-CONTACT SURFACES and UTENSILS shall be
Frequency
9
Before Use After Cleaning.*
UTENSILS and FOOD-CONTACT SURFACES of EQUIPMENT shall be SANITIZED
before use after cleaning.
10
11
4-702.11
SANITIZED.
Methods
4-703.11
Hot Water and Chemical.*
12
After being cleaned, EQUIPMENT FOOD-CONTACT SURFACES and UTENSILS
13
shall be
14
(A)
in:
Hot water manual operations by immersion for at least
30 seconds and as specified under § 4-501.111;
15
16
SANITIZED
(B)
Hot water mechanical operations
by
being
cycled
17
through
18
4-501.15, 4-501.112, and 4-501.113 and achieving a
19
UTENSIL
20
by an irreversible registering temperature indicator; or
21
(C)
EQUIPMENT
that is set up as specified under §§
surface temperature of 71oC (160oF) as measured
Chemical
manual or mechanical operations, including
22
the
application of
23
manual
24
methods,
25
4-501.114 by providing:
26
(1)
SANITIZING
swabbing,
brushing,
using a
solution
chemicals by immersion,
or
pressure
spraying
as specified under
§
Except as specified under Subparagraph (C)(2) of
27
this
section, an
28
seconds for
29
¶ 4-501.114(A),
151
exposure
time of at least 10
a chlorine solution specified under
1
(2)
04.05.11
An exposure time of at least 7 seconds for a
2
chlorine solution of 50 MG/L that has a
3
or less and a temperature of at least 38oC (100oF)
or a
4
PH
PH
of 10
of 8 or less and a temperature of at
least 24oC (75oF),
5
6
(3)
7
An exposure time of at least
other chemical
8
(4)
9
SANITIZING
30 seconds
for
solutions, or
An exposure time used in relationship with a
combination of temperature, concentration, and
10
that,
when
11
SANITIZATION
12
1-201.10(B).
evaluated
as
for
defined
efficacy,
in
PH
yields
Subparagraph
13
14
4-8
15
LAUNDERING
Subparts
16
4-801
Objective
17
4-802
Frequency
18
4-803
Methods
4-801.11
Clean Linens.
19
20
Objective
21
Clean
22
soiling matter.
23
24
Frequency
LINENS
4-802.11
(A)
shall be free from
LINENS that
do not come in direct contact with
shall be laundered
26
wet, sticky, or visibly soiled.
(B)
residues and other
Specifications.
25
27
FOOD
FOOD
between operations if they become
Cloth gloves used as specified in & 3-304.15(D) shall be
28
laundered before being used with a different type of raw
29
animal
30
(C)
FOOD
such as beef,
FISH,
lamb, pork or
POULTRY.
LINENS and napkins that are used as specified under
152
1
§ 3-304.13
and
cloth
2
between each use.
napkins
shall
be
04.05.11
laundered
3
(D)
Wet wiping cloths shall be laundered daily.
4
(E)
Dry wiping cloths shall be laundered as necessary to
5
prevent contamination of
FOOD
and clean serving
UTENSILS.
6
7
Methods
4-803.11
Storage of Soiled Linens.
8
Soiled
9
receptacles or clean, washable laundry bags and stored and
LINENS
10
transported
to
11
EQUIPMENT,
clean
12
ARTICLES.
13
4-803.12
14
(A)
15
16
shall
be
prevent
UTENSILS,
kept
in
clean,
contamination
and
nonabsorbent
of
FOOD,
SINGLE-SERVICE
and
clean
SINGLE-USE
Mechanical Washing.
Except as specified in ¶ (B)
of
this
section,
LINENS
shall be mechanically washed.
(B)
In
in which only wiping cloths are
FOOD ESTABLISHMENTS
17
laundered as specified
18
cloths may be laundered in a mechanical washer, sink
19
designated
20
WAREWASHING
21
as specified under § 4-501.14.
22
4-803.13
23
(A)
only
for
or
FOOD
in ¶ 4-301.15(B),
laundering
wiping
the wiping
cloths,
or
a
preparation sink that is cleaned
Use of Laundry Facilities.
Except as specified in ¶ (B) of this section, laundry
24
facilities on the
25
be used only for the washing and drying of items used
26
in the operation of the establishment.
27
(B)
PREMISES
of a
FOOD ESTABLISHMENT
Separate laundry facilities located on the
PREMISES
shall
for the
28
purpose of general laundering such as for institutions
29
providing boarding and lodging may also be used for
30
laundering
FOOD ESTABLISHMENT
153
items.
04.05.11
1
2
4-9
3
PROTECTION OF CLEAN ITEMS
Subparts
4
4-901
Drying
5
4-902
Lubricating and Reassembling
6
4-903
Storing
7
4-904
Preventing Contamination
4-901.11
Equipment and Utensils, Air-Drying Required.
8
9
Drying
10
After cleaning and
11
(A)
SANITIZING, EQUIPMENT
Shall be air-dried or used
12
specified
13
Tolerance exemptions for
14
for
15
surface
16
and
17
(B)
in
use
the
in
first
after
UTENSILS:
adequate draining
as
paragraph of 40 CFR 180.940
active and inert ingredients
antimicrobial
SANITIZING
and
formulations
(food-contact
solutions), before contact with
Shall not be cloth dried except that
18
been
19
maintained clean and dry.
UTENSILS
air-dried may be polished with
FOOD;
that have
cloths that are
20
4-901.12
21
Wiping cloths laundered in a
22
not
23
4-301.15(B) shall be air-dried in a location and in a manner
24
that prevents contamination of
25
and
26
cloths. This section does not apply if wiping cloths are stored
27
after laundering in a
28
§ 4-501.114.
have
Wiping Cloths, Air-Drying Locations.
a
mechanical
SINGLE-SERVICE
and
FOOD
clothes
ESTABLISHMENT
dryer
as
that does
specified
in ¶
FOOD, EQUIPMENT, UTENSILS, LINENS,
SINGLE-USE ARTICLES
SANITIZING
and the wiping
solution as specified under
29
Lubricating
4-902.11
Food-Contact Surfaces.
30
and
Lubricants as specified under § 7-205.11 shall be applied to
154
1
Reassembling
2
does not contaminate
3
4-902.12
4
EQUIPMENT
5
SURFACES
6
Storing
FOOD-CONTACT SURFACES.
Equipment.
shall
be
reassembled
so
that
FOOD-CONTACT
are not contaminated.
4-903.11
Equipment, Utensils, Linens, and Single-Service
and Single-Use Articles.
7
8
04.05.11
that require lubrication in a manner that
FOOD-CONTACT SURFACES
(A)
9
Except
as
specified in ¶ (D) of this section, cleaned
EQUIPMENT and UTENSILS, laundered LINENS, and SINGLE-SERVICE
10
and
SINGLE-USE ARTICLES
11
(1)
In a clean, dry location;
12
(2)
Where they are not exposed to splash, dust, or
13
other contamination; and
14
15
shall be stored:
(B)
(3)
At least 15 cm (6 inches) above the floor.
Clean
EQUIPMENT
and
UTENSILS
shall be stored as specified
16
under ¶ (A) of this section and shall be stored:
17
(1)
18
a self-draining position that allows air drying;
and
19
20
In
(2)
(C)
21
Covered or inverted.
SINGLE-SERVICE and
SINGLE-USE ARTICLES
shall be stored as
specified under ¶ (A) of this section and shall be kept in
22
the original protective
23
means that afford protection from contamination until
24
used.
25
(D)
PACKAGE
or stored by using other
Items that are kept in closed PACKAGES may be stored less
26
than 15 cm (6 inches) above the floor on dollies, pallets,
27
racks, and skids that are designed as specified under §
28
4-204.122
29
4-903.12
30
(A)
Prohibitions.
Except as specified in ¶ (B) of this section, cleaned and
155
04.05.11
laundered LINENS, and SINGLE-
1
SANITIZED EQUIPMENT, UTENSILS,
2
SERVICE
3
(1)
In locker rooms;
4
(2)
In toilet rooms;
5
(3)
In garbage rooms;
6
(4)
In mechanical rooms;
7
(5)
Under sewer lines that are not shielded to intercept
8
and
SINGLE-USE ARTICLES
shall not be stored:
potential drips;
9
(6)
Under
leaking
water
lines
including
leaking
10
automatic fire sprinkler heads or under lines on
11
which water has condensed;
12
(7)
Under open stairwells; or
13
(8)
Under other sources of contamination.
14
(B)
Laundered LINENS and SINGLE-SERVICE and SINGLE-USE ARTICLES
15
that are
16
be stored in a locker room.
17
Preventing
4-904.11
18
Contamination
(A)
or in a facility such as a cabinet may
PACKAGED
Kitchenware and Tableware.
SINGLE-SERVICE and
SINGLE-USE ARTICLES
19
SANITIZED
20
dispensed so that contamination of
21
surfaces is prevented.
22
(B)
UTENSILS
and cleaned and
shall be handled, displayed, and
FOOD-
and lip-contact
Knives, forks, and spoons that are not prewrapped shall
23
be presented so that only the handles are touched
24
EMPLOYEES
25
provided.
26
(C)
Except
and by
CONSUMERS
if
CONSUMER
by
self-service is
as specified under ¶ (B) of this section,
27
SERVICE ARTICLES
28
shall be furnished for
29
original individual wrapper intact or from an
30
dispenser.
SINGLE-
that are intended for FOOD- or lip-contact
156
CONSUMER
self-service with the
APPROVED
04.05.11
1
4-904.12
Soiled and Clean Tableware.
2
Soiled
3
drinking areas and handled so that clean
4
contaminated.
5
4-904.13
6
(A)
9
shall be removed from
CONSUMER
eating and
TABLEWARE
is not
Preset Tableware.
TABLEWARE
that
is
preset
shall
be
protected
from
contamination by being wrapped, covered, or inverted.
7
8
TABLEWARE
(B)
When
TABLEWARE
is preset, exposed, unused settings
shall be:
10
(1)
Removed when a
11
(2)
Cleaned
12
settings
13
seated.
and
are
14
15
16
17
18
19
20
21
157
CONSUMER
SANITIZED
is seated; or
before further use if the
not removed
when a
CONSUMER
is
04..05.11
1
Chapter
2
5
3
Parts
Water, Plumbing, and Waste
4
5-1
WATER
5
5-2
PLUMBING SYSTEM
6
5-3
MOBILE WATER TANK AND MOBILE FOOD ESTABLISHMENT WATER
7
TANK
8
5-4
SEWAGE, OTHER LIQUID WASTE, AND RAINWATER
9
5-5
REFUSE, RECYCLABLES, AND RETURNABLES
5-1
WATER
10
11
12
Subparts
13
5-101
Source
14
5-102
Quality
15
5-103
Quantity and Availability
16
5-104
Distribution, Delivery, and Retention
5-101.11
Approved System.*
17
18
Source
19
DRINKING
20
is:
21
(A)
A
22
(B)
A nonpublic
23
WATER
shall be obtained from an
PUBLIC WATER SYSTEM;
APPROVED
source that
or
WATER SYSTEM
that is constructed, maintained,
and operated according to LAW.
24
5-101.12
System Flushing and Disinfection.*
25
A DRINKING WATER system shall be flushed and disinfected before being
26
placed in service after construction, repair, or modification and
27
after an emergency situation, such as a flood, that may introduce
28
contaminants to the system.
158
04..05.11
1
5-101.13
2
BOTTLED DRINKING WATER used or sold in a
3
obtained from
4
Processing and Bottling of Bottled
5
Quality
Bottled Drinking Water.*
5-102.11
APPROVED
DRINKING WATER.
Standards.*
Except as specified under § 5-102.12:
7
(A)
Water from a
PUBLIC WATER SYSTEM
8
National
9
DRINKING WATER
(B)
11
Primary
Drinking
WATER
5-102.12
13
(A)
Water
shall
meet 40 CF141 -
Regulations
and
state
quality standards; and
Water from a nonPUBLIC
12
shall be
sources in accordance with 21 CFR 129 -
6
10
FOOD ESTABLISHMENT
WATER SYSTEM
shall meet state
DRINKING
quality standards.
Nondrinking Water.*
A nonDRINKING WATER supply shall be used only if its use is
APPROVED.
14
15
(B)
NonDRINKING
shall
WATER
be
used
only
16
purposes such as air conditioning, nonFOOD
17
fire protection, and irrigation.
for
nonculinary
EQUIPMENT
cooling,
18
5-102.13
19
Except when used as specified under §5-102.12, water from a nonPUBLIC
20
WATER SYSTEM
21
required by state water quality regulations.
22
5-102.14
23
The most recent sample report for the nonpublic
24
be retained on file in the
25
maintained as specified by state water quality regulations.
26
Quantity and
5-103.11
27
Availability
(A)
28
29
30
Sampling.
shall be sampled and tested at least annually and as
Sample Report.
FOOD ESTABLISHMENT
shall
or the report shall be
Capacity.*
The water source and system shall be of sufficient capacity
to meet the peak water demands of the
(B)
WATER SYSTEM
Hot
water
generation
and
distribution
FOOD ESTABLISHMENT.
systems
shall
be
sufficient to meet the peak hot water demands throughout the
159
04..05.11
1
FOOD ESTABLISHMENT.
2
5-103.12
3
Water under pressure shall be provided to all fixtures,
4
and non
5
water
6
TEMPORARY FOOD ESTABLISHMENT
7
Pressure.
FOOD EQUIPMENT
supplied
as
EQUIPMENT,
that are required to use water except that
specified
under ¶¶ 5-104.12(A) and (B) to a
or in response to a temporary interruption
of a water supply need not be under pressure.
8
Distribution,
5-104.11
9
Delivery, and
Water shall be received from the source through the use of:
Retention
(A)
An
(B)
One or more of the following that shall be constructed,
10
11
System.
APPROVED
public water main; or
12
maintained, and operated according to
LAW :
13
(1)
pumps,
Nonpublic
water
main,
water
pipes, hoses,
connections, and other appurtenances,
14
15
(2)
Water transport vehicles, or
16
(3)
Water containers.
17
5-104.12
18
Water meeting the requirements specified under Subparts 5-101,
19
5-102, and 5-103 shall be made available for a mobile facility, for a
20
TEMPORARY FOOD ESTABLISHMENT
Alternative Water Supply.
without a permanent water supply, and
21
for a
22
supply through:
23
(A)
A supply of containers of commercially BOTTLED DRINKING WATER;
24
(B)
One or more closed portable water containers;
25
(C)
An enclosed vehicular water tank;
26
(D)
An on-PREMISES water storage tank; or
27
(E)
Piping, tubing, or hoses connected to an adjacent
28
29
FOOD ESTABLISHMENT
source.
5-2
PLUMBING SYSTEM
160
with a temporary interruption of its water
APPROVED
04..05.11
1
Subparts
2
5-201
Materials
3
5-202
Design, Construction, and Installation
4
5-203
Numbers and Capacities
5
5-204
Location and Placement
6
5-205
Operation and Maintenance
5-201.11
Approved.*
7
8
Materials
9
(A)
A
and hoses conveying water shall be
PLUMBING SYSTEM
10
constructed and repaired with
11
to
12
(B)
Design,
5-202.11
14
Construction,
(A)
15
and Installation
A
materials according
LAW .
A water filter shall be made of
13
16
APPROVED
SAFE MATERIALS.
Approved System and Cleanable Fixtures.*
PLUMBING SYSTEM
shall be designed, constructed,
and
installed according to LAW.
(B)
17
A
PLUMBING FIXTURE
urinal shall be
18
5-202.12
19
(A)
A
such as a
HANDWASHING SINK,
EASILY CLEANABLE.
toilet, or
N
Handwashing Sink, Installation.
HANDWASHING SINK
shall be equipped to provide water at a
20
temperature of at least 38oC (100oF) through a mixing valve
21
or combination faucet.
22
(B)
23
24
A steam mixing valve shall not be used at a
HANDWASHING
SINK.
(C)
A self-closing, slow-closing, or metering faucet shall provide
25
a flow of water for at least 15 seconds without the need to
26
reactivate the faucet.
27
28
29
(D)
An automatic handwashing facility shall be installed in
accordance with manufacturer’s instructions.
5-202.13
Backflow Prevention, Air Gap.*
161
1
04..05.11
An air gap between the water supply inlet and the flood level rim
2
of the
3
be at least twice the diameter of the water supply inlet and shall
4
not be less than 25 mm (1 inch).
5
5-202.14
6
A backflow or backsiphonage prevention device installed on a
7
water supply system shall meet American Society of Sanitary
8
Engineering (A.S.S.E.) standards for construction, installation,
9
maintenance, inspection, and testing for that specific application
PLUMBING FIXTURE, EQUIPMENT,
or nonFOOD
EQUIPMENT
shall
Backflow Prevention Device, Design Standard.
10
and type of device.
11
5-202.15
12
A water filter, screen, and other water conditioning device installed on
13
water lines shall be designed to facilitate disassembly for periodic
14
servicing and cleaning.
15
replaceable type.
16
Numbers and
5-203.11
17
Capacities
(A)
Conditioning Device, Design.
A water filter element shall be of the
Handwashing Sinks.*
Except as specified in ¶¶ (B) and (C) of this section, at
18
least 1
19
necessary for their convenient use by
20
specified under § 5-204.11, and not fewer than the number
21
of
HANDWASHING SINKS required
If
APPROVED
22
(B)
HANDWASHING SINK,
a number of
by
LAW
HANDWASHING SINKS
EMPLOYEES
in areas
shall be provided.
and capable of removing the types of soils
23
encountered in the
24
handwashing facilities may be substituted for HANDWASHING SINKS
25
in a FOOD ESTABLISHMENT that has at least one HANDWASHING SINK.
26
(C)
If
FOOD
operations involved, automatic
APPROVED, when FOOD exposure
is limited and HANDWASHING
27
SINKS
are not conveniently available, such as in some mobile or
28
TEMPORARY FOOD ESTABLISHMENTS
29
LOCATIONS, EMPLOYEES may use chemically treated
30
handwashing.
162
or at some
VENDING MACHINE
towelettes for
04..05.11
1
5-203.12
2
At least 1 toilet and not fewer than the toilets required by
3
shall
4
substituted for toilets, the substitution shall be done as specified
5
in
6
5-203.13
7
At least 1 service sink or 1 curbed cleaning facility equipped with
8
a floor drain shall be provided and conveniently located for the
9
cleaning of mops or similar wet floor cleaning tools and for the
be
Toilets and Urinals.*
provided.
If
authorized
by
LAW
and
LAW
urinals
are
LAW .
Service Sink.
10
disposal of mop water and similar liquid waste.
11
5-203.14
12
A
13
solid, liquid, or gas contaminant into the water supply system at
14
each point of use at the
15
bibb if a hose is attached or on a hose bibb if a hose is not
16
attached and backflow prevention is required by
17
(A)
Providing an air gap as specified under § 5-202.13; or
18
(B)
Installing
Backflow Prevention Device, When Required.*
PLUMBING SYSTEM
19
an
shall be installed to preclude backflow of a
FOOD ESTABLISHMENT,
APPROVED
backflow
including on a hose
LAW ,
by:
prevention device as
Specified under § 5-202.14.
20
5-203.15
21
(A)
22
202.13, a double check valve with an intermediate vent preceded
23
by a screen of not less than 100 mesh to 25.4 mm (100 mesh
24
to 1 inch) shall be installed upstream from a carbonating device
25
and downstream from any copper in the water supply line.
26
(B)
27
need not be of the vented type if an air gap or vented backflow
28
prevention device has been otherwise provided as specified under
29
(A) of this section.
30
Location and
Backflow Prevention Device, Carbonator.*
If not provided with an air gap as specified under § 5-
A single or double check valve attached to the carbonator
5-204.11
Handwashing Sinks.*
163
04..05.11
1
Placement
2
A
HANDWASHING SINK
(A)
3
shall be located:
To allow convenient use by
FOOD
dispensing, and
EMPLOYEES
WAREWASHING
in
FOOD
preparation,
areas; and
4
(B)
In, or immediately adjacent to, toilet rooms.
5
5-204.12
6
A backflow prevention device shall be located so that it may be
7
serviced and maintained.
8
5-204.13
9
A water filter, screen, and other water conditioning device
10
installed on water lines shall be located to facilitate disassembly
11
for periodic servicing and cleaning.
12
Operation and
5-205.11
13
Maintenance
(A)
(B)
16
17
Conditioning Device, Location.
Using a Handwashing Sink.
HANDWASHING SINK
shall be maintained so that it is
accessible at all times for
14
15
A
Backflow Prevention Device, Location.
A
HANDWASHING SINK
EMPLOYEE
use.
shall not be used for purposes other
than handwashing.
(C)
An
automatic handwashing
facility
shall
be used in
accordance with manufacturer’s instructions.
18
19
5-205.12
20
(A)
A
Prohibiting a Cross Connection.*
PERSON
shall not create a cross connection by
21
connecting a pipe or conduit between the DRINKING WATER
22
system and a non
23
system of unknown quality.
24
(B)
DRINKING WATER
The piping of a nonDRINKING
system or a water
WATER
system shall be
25
durably identified so that it is readily distinguishable from
26
piping that carries
27
28
5-205.13
DRINKING WATER.
N
Scheduling Inspection and Service for a Water
System Device.
164
1
04..05.11
A device such as a water treatment device or backflow preventer
2
shall be scheduled for inspection and service, in accordance with
3
manufacturer's instructions and as necessary to prevent device
4
failure based on local water conditions, and records demonstrating
5
inspection and service shall be maintained by the
6
CHARGE.
7
5-205.14
8
(A)
9
PERSON IN
Water Reservoir of Fogging Devices, Cleaning.*
A reservoir that is used to supply water to a device such
as a produce fogger shall be:
10
(1)
11
Maintained
in
accordance
with
manufacturer's
specifications; and
12
(2)
Cleaned in accordance with manufacturer's specifications
13
or according to the procedures specified under ¶(B)
14
of this section, whichever is more stringent.
15
(B)
Cleaning procedures shall include at least the following
16
steps and shall be conducted at least once a week:
17
(1)
18
Draining and complete disassembly of the water and
aerosol contact parts;
19
(2)
20
Brush-cleaning the reservoir, aerosol tubing, and
discharge nozzles with a suitable detergent solution;
21
(3)
22
Flushing the complete system with water to remove the
detergent solution and particulate accumulation; and
23
(4)
Rinsing by immersing, spraying, or swabbing the
24
reservoir, aerosol tubing, and discharge nozzles with
25
at least 50 MG/L hypochlorite solution.
26
5-205.15
System Maintained in Good Repair.*
27
A
28
(A)
Repaired according to
29
(B)
Maintained in good repair.S
PLUMBING SYSTEM
shall be:
30
165
LAW ;
and
1
5-3
04..05.11
MOBILE WATER TANK AND MOBILE FOOD ESTABLISHMENT WATER
2
TANK
3
Subparts
4
5-301
Materials
5
5-302
Design and Construction
6
5-303
Numbers and Capacities
7
5-304
Operation and Maintenance
5-301.11
Approved.
8
9
Materials
10
Materials that are used in the construction of a mobile water tank,
11
mobile FOOD ESTABLISHMENT water tank, and appurtenances shall be:
12
(A)
Safe;
13
(B)
Durable, CORROSION-RESISTANT, and nonabsorbent; and
14
(C)
Finished to have a
SMOOTH, EASILY CLEANABLE
15
Design and
5-302.11
16
Construction
A mobile water tank shall be:
surface.
Enclosed System, Sloped to Drain.
17
(A)
Enclosed from the filling inlet to the discharge outlet; and
18
(B)
Sloped to an outlet that allows complete drainage of the
19
20
tank.
5-302.12
21
Inspection and Cleaning Port, Protected and
Secured.
22
If a water tank is designed with an access port for inspection and
23
cleaning, the opening shall be in the top of the tank and:
24
(A)
Flanged upward at least 13 mm (one-half inch); and
25
(B)
Equipped with a port cover assembly that is:
26
(1)
27
Provided
with a gasket and
a device for securing
the cover in place, and
28
(2)
29
5-302.13
Flanged to overlap the opening and sloped to drain.
“V” Type Threads, Use Limitation.
166
1
04..05.11
A fitting with “V” type threads on a water tank inlet or outlet shall
2
be allowed only when a hose is permanently attached.
3
5-302.14
4
If provided, a water tank vent shall terminate in a downward
5
direction and shall be covered with:
6
(A)
7
Tank Vent, Protected.
16 mesh to 25.4 mm (16 mesh to 1 inch) screen or
equivalent when the vent is in a protected area; or
8
(B)
9
A protective filter when the vent is in an area that is not
protected from windblown dirt and debris.
10
5-302.15
11
(A)
12
Inlet and Outlet, Sloped to Drain.
A water tank and its inlet and outlet shall be sloped to
drain.
13
(B)
A water tank inlet shall be positioned so that it is protected
14
from contaminants such as waste discharge, road dust, oil,
15
or grease.
16
5-302.16
17
A hose used for conveying
18
be:
19
(A)
Safe;
20
(B)
Durable,
21
(C)
Resistant to pitting, chipping, crazing, scratching, scoring,
22
Hose, Construction and Identification.
DRINKING WATER
CORROSION-RESISTANT,
from a water tank shall
and nonabsorbent;
distortion, and decomposition;
23
(D)
Finished with a
24
(E)
Clearly
25
and
SMOOTH
durably
interior surface; and
identified
as
to
its
use
if
not
permanently attached.
26
Numbers and
5-303.11
Filter, Compressed Air.
27
Capacities
A filter that does not pass oil or oil vapors shall be installed in
28
the air supply line between the compressor and
29
system when compressed air
30
tank system.
167
DRINKING WATER
is used to pressurize the water
04..05.11
1
5-303.12
Protective Cover or Device.
2
A cap and keeper chain, closed cabinet, closed storage tube, or
3
other
4
water inlet, outlet, and hose.
5
5-303.13
6
A mobile
7
(A)
19.1 mm (three-fourths inch) in inner diameter or less; and
8
(B)
Provided with a hose connection of a size or type that will
APPROVED
protective cover or device shall be provided for a
Mobile Food Establishment Tank Inlet.
FOOD ESTABLISHMENT'S
water tank inlet shall be:
prevent its use for any other service.
9
10
Operation and
5-304.11
System Flushing and Sanitization.*
11
Maintenance
A water tank, pump, and hoses shall be flushed and
being
placed
in
service
after
SANITIZED
12
before
13
modification, and periods of nonuse.
14
5-304.12
15
A
16
and other contamination of the water supply are prevented.
17
5-304.13
18
If not in use, a water tank and hose inlet and outlet fitting shall
19
be protected using a cover or device as specified under § 5-303.12.
20
5-304.14
21
(A)
PERSON shall
operate a water tank, pump, and hoses so that backflow
Protecting Inlet, Outlet, and Hose Fitting.
Tank, Pump, and Hoses, Dedication.
Except as specified in ¶(B) of this section, a water tank,
pump, and hoses used for conveying
23
used for no other purpose.
(B)
Water tanks, pumps, and hoses
25
be used for conveying
26
and
SANITIZED
29
5-4
DRINKING WATER
DRINKING WATER
if they are cleaned
before they are used to convey water.
SEWAGE, OTHER LIQUID WASTE, AND RAINWATER
Subparts
168
shall be
APPROVED for liquid FOODS may
27
28
repair
Using a Pump and Hoses, Backflow Prevention.
22
24
construction,
04..05.11
1
5-401
Mobile Holding Tank
2
5-402
Retention, Drainage, and Delivery
3
5-403
Disposal Facility
Capacity and Drainage.
4
5
Mobile Holding
5-401.11
6
Tank
A
7
SEWAGE
(A)
8
holding tank in a mobile
FOOD ESTABLISHMENT
shall be:
Sized 15 percent larger in capacity than the water supply
tank; and
9
(B)
10
Sloped to a drain that is 25 mm (1 inch) in inner diameter or
greater, equipped with a shut-off valve.
11
Retention,
5-402.10
Establishment Drainage System.
12
Drainage, and
FOOD
13
Delivery
that convey
14
design,
under ¶ 5-202.11(A).
15
construction, and
16
installation
drainage
ESTABLISHMENT
SEWAGE
systems, including grease traps,
shall be designed and installed as specified
17
5-402.11
Backflow Prevention.*
18
(A)
19
direct connection shall not exist between the SEWAGE system and a
20
drain originating from EQUIPMENT in which FOOD, portable EQUIPMENT,
21
or UTENSILS are placed.
22
(B)
Except as specified in ¶¶ (B), (C), and (D) of this section, a
Paragraph (A) of this section does not apply to floor drains
23
that originate in refrigerated spaces that are constructed as
24
an integral part of the building.
25
(C)
If allowed by
LAW ,
a
WAREWASHING
machine may have a
26
direct connection between its waste outlet and a floor drain
27
when the machine is located within 1.5 m (5 feet) of a
28
trapped floor drain and the machine outlet is connected to
29
the inlet side of a properly vented floor drain trap.
169
1
(D)
If allowed by
LAW ,
a
WAREWASHING
04..05.11
or culinary sink may have
a direct connection.
2
3
location and
5-402.12
4
placement
If used, a grease trap shall be located to be easily accessible for
5
Grease Trap.
cleaning.
6
operation and
5-402.13
Conveying Sewage.*
7
maintenance
SEWAGE shall be conveyed to the point of
8
APPROVED
9
SEWAGE
sanitary
SEWAGE
disposal through an
system or other system, including use of
transport vehicles, waste retention tanks, pumps, pipes,
10
hoses, and connections that are constructed, maintained, and
11
operated according to
12
5-402.14
13
SEWAGE and other liquid wastes shall be removed from a mobile
14
FOOD ESTABLISHMENT
15
SEWAGE
transport vehicle in such a way
16
HAZARD
or nuisance is not created.
17
5-402.15
18
A tank for liquid waste retention shall be thoroughly flushed and
19
drained in a sanitary manner during the servicing operation.
20
Disposal Facility
5-403.11
LAW .
Removing Mobile Food Establishment Wastes.
at an
APPROVED
waste
that a public health
Approved Sewage Disposal System.*
design and
SEWAGE shall be disposed through an
22
construction
(A)
A public
(B)
An individual
24
or by a
Flushing a Waste Retention Tank.
21
23
SERVICING AREA
SEWAGE
APPROVED
facility that is:
treatment plant; or
SEWAGE
disposal system
that is sized,
constructed, maintained, and operated according to LAW.
25
5-403.12
Other Liquid Wastes and Rainwater.
26
Condensate drainage and other nonSEWAGE liquids and rainwater
27
shall be drained from point of discharge to disposal according to
28
LAW .
29
30
5-5
REFUSE, RECYCLABLES, AND RETURNABLES
170
04..05.11
1
Subparts
2
5-501
Facilities on the Premises
3
5-502
Removal
4
5-503
Facilities for Disposal and Recycling
Indoor Storage Area.
5
Facilities on the
5-501.10
6
Premises
If located within the
7
materials, design,
REFUSE,
8
construction, and
specified under §§ 6-101.11, 6-201.11–6-201.18, 6-202.15, and
9
installation
6-202.16
FOOD ESTABLISHMENT,
a storage area for
recyclables, and returnables shall meet the requirements
10
5-501.11
Outdoor Storage Surface.
11
An outdoor storage surface for
12
shall be constructed of nonabsorbent material such as concrete
13
or asphalt and shall be
14
5-501.12
15
If used, an outdoor enclosure for REFUSE, recyclables, and returnables
16
shall be constructed of durable and cleanable materials.
17
5-501.13
18
(A)
REFUSE,
SMOOTH,
recyclables, and returnables
durable, and sloped to drain.
Outdoor Enclosure.
Receptacles.
Except as specified
in ¶ (B) of this section, receptacles
19
and waste handling units
20
returnables and for use with materials containing
21
residue
22
resistant, leakproof, and non absorbent.
23
(B)
shall
be
durable,
for
REFUSE,
recyclables, and
FOOD
cleanable, insect-and rodent-
Plastic bags and wet strength paper bags may be used to
24
line receptacles for storage inside the
25
or within closed outside receptacles.
26
5-501.14
27
Except for a receptacle for
28
REFUSE
29
5-501.15
30
(A)
FOOD ESTABLISHMENT,
Receptacles in Vending Machines.
BEVERAGE
bottle crown closures, a
receptacle shall not be located within a
VENDING MACHINE.
Outside Receptacles.
Receptacles
and
171
waste
handling
units
for
REFUSE,
1
04..05.11
recyclables, and returnables used with materials containing
2
FOOD
3
shall be designed and constructed to have tight-fitting lids,
4
doors, or covers.
5
(B)
residue and used outside the
FOOD ESTABLISHMENT
Receptacles and waste handling units for REFUSE and recyclables
6
such as an on-site compactor shall be installed so that
7
accumulation of debris and insect and rodent attraction and
8
harborage are minimized and effective cleaning is facilitated
9
around and, if the unit is not installed flush with the base
pad, under the unit.
10
11
numbers and
12
capacities
13
5-501.16
Storage Areas, Rooms, and Receptacles Capacity,
and Availability.
(A)
An inside storage room and area and outside storage area
14
and enclosure,
and receptacles shall be of sufficient
15
capacity to hold
REFUSE,
16
accumulate.
17
(B)
recyclables,
and returnables that
A receptacle shall be provided in each area of the
18
ESTABLISHMENT
19
commonly discarded, or where recyclables or returnables
20
are placed.
21
(C)
or
PREMISES
where
FOOD
REFUSE
is generated or
If disposable towels are used at handwashing lavatories,
22
a waste receptacle shall be located at each lavatory or
23
group of adjacent lavatories.
24
5-501.17
Toilet Room Receptacle, Covered.
25
A toilet room used by females shall be provided with a covered
26
receptacle for sanitary napkins.
27
5-501.18
28
(A)
Cleaning Implements and Supplies.
Except
as
specified
implements
in ¶ (B)
of
this section, suitable
29
cleaning
30
pumps, hot water, steam, and detergent shall be provided
172
and supplies such as high pressure
1
as necessary for effective cleaning
2
waste
3
returnables.
4
(B)
If
handling
units
for
04..05.11
of receptacles and
REFUSE,
recyclables,
APPROVED, off-PREMISES-based cleaning services
and
may be used
5
if on-PREMISES cleaning implements and supplies are not
6
provided.
7
location and
8
placement
9
5-501.19
Storage Areas, Redeeming Machines, Receptacles
and Waste Handling Units, Location.
(A)
An area designated for
REFUSE,
recyclables, returnables, and,
10
except as specified in ¶(B) of this section, a redeeming machine
11
for recyclables or returnables shall be located so that it is
12
separate from
13
SERVICE
14
or nuisance is not created.
15
(B)
16
and
FOOD, EQUIPMENT, UTENSILS, LINENS,
SINGLE-USE ARTICLES
and
SINGLE-
and a public health
HAZARD
A redeeming machine may be located in the
storage area or
CONSUMER
area of a
17
FOOD, EQUIPMENT, UTENSILS, LINENS,
18
SINGLE-USE ARTICLES
19
machines and a public health
20
created.
21
(C)
The
PACKAGED FOOD
FOOD ESTABLISHMENT
and
SINGLE-SERVICE
if
and
are not subject to contamination from the
location of receptacles
22
REFUSE,
23
public health
24
cleaning of adjacent space.
HAZARD
and
or nuisance is not
waste handling units for
recyclables, and returnables shall not
HAZARD
or nuisance or
create a
interfere with the
25
operation and
5-501.110
Storing Refuse, Recyclables, and Returnables.
26
maintenance
REFUSE, recyclables, and returnables shall be stored in receptacles
27
or waste handling units so that they are inaccessible to insects
28
and rodents.
29
5-501.111
30
Storage areas, enclosures, and receptacles for
Areas, Enclosures, and Receptacles, Good Repair.
173
REFUSE,
recyclables,
04..05.11
1
and returnables shall be maintained in good repair.
2
5-501.112
3
(A)
Outside Storage Prohibitions.
Except
as
specified
in &(B)
of
this
section,
REFUSE
4
receptacles not meeting the requirements specified under
5
¶5-501.13(A) such as receptacles that are not rodent-resistant,
6
unprotected plastic bags and paper bags, or baled units that
7
contain materials with FOOD residue may not be stored outside.
8
(B)
9
Cardboard or other packaging material that does not contain
FOOD
residues
and
that
is
awaiting regularly scheduled
10
delivery to a recycling or disposal site may be stored outside
11
without being in a covered receptacle if it is stored so that
12
it does not create a rodent harborage problem.
13
5-501.113
Covering Receptacles.
14
Receptacles and waste handling units for
15
returnables shall be kept covered:
16
(A)
Inside the
FOOD ESTABLISHMENT
17
(1)
Contain
18
(2)
After they are filled; and
19
(B)
20
FOOD
REFUSE,
recyclables, and
if the receptacles and units:
residue and are not in continuous use;
With tight-fitting lids or doors if kept outside the
FOOD
ESTABLISHMENT.
21
5-501.114
22
Drains
23
recyclables, and returnables shall have drain plugs in place.
24
5-501.115
25
A storage area and enclosure for REFUSE, recyclables, or returnables
26
shall be maintained free of unnecessary items, as specified under
27
6-501.114, and clean.
28
5-501.116
29
(A)
30
Using Drain Plugs.
in receptacles and
waste handling units for
REFUSE,
Maintaining Refuse Areas and Enclosures.
Cleaning Receptacles.
Receptacles and waste handling units for
REFUSE, recyclables,
and returnables shall be thoroughly cleaned in a way that
174
04..05.11
or
1
does not contaminate
2
SINGLE-SERVICE
3
be disposed of as specified under § 5-402.13.
4
(B)
FOOD, EQUIPMENT, UTENSILS, LINENS,
and SINGLE-USE ARTICLES, and waste water shall
Soiled receptacles and waste handling units for
REFUSE,
5
recyclables, and returnables shall be cleaned at a frequency
6
necessary to prevent them from developing a buildup of soil
7
or becoming attractants for insects and rodents.
8
Removal
9
5-502.11
Frequency.
REFUSE, recyclables, and returnables shall be removed from the
10
PREMISES
11
objectionable odors and other conditions that attract or harbor
12
insects and rodents.
13
5-502.12
14
REFUSE, recyclables, and returnables shall be removed from the
15
PREMISES
16
(A)
17
at a frequency that will minimize the development of
Receptacles or Vehicles.
by way of:
Portable receptacles that are constructed and maintained
according to
18
(B)
19
LAW ;
or
A transport vehicle that is constructed, maintained, and
operated according to
LAW .
20
Facilities for
5-503.11
Community or Individual Facility.
21
Disposal and
Solid waste not disposed of through the
22
Recycling
through grinders and pulpers shall be recycled or disposed of in
SEWAGE
system such as
23
an
24
facility; or solid waste shall be disposed of in an individual
25
facility
26
constructed, maintained, and operated according to
APPROVED
such
public or private community recycling or
as
a
landfill
175
or
incinerator
which
is
LAW .
REFUSE
REFUSE
sized,
04.05.11
1
Chapter
2
6
3
Parts
4
6-1
MATERIALS FOR CONSTRUCTION AND REPAIR
5
6-2
DESIGN, CONSTRUCTION, AND INSTALLATION
6
6-3
NUMBERS AND CAPACITIES
7
6-4
LOCATION AND PLACEMENT
8
6-5
MAINTENANCE AND OPERATION
6-1
MATERIALS FOR CONSTRUCTION AND REPAIR
Physical Facilities
9
10
11
Subparts
12
6-101
Indoor Areas
13
6-102
Outdoor Areas
6-101.11
Surface Characteristics.
14
15
16
Indoor Areas
(A)
Except as specified in ¶ (B) of this section, materials for
17
indoor floor, wall, and ceiling surfaces under conditions of
18
normal use shall be:
19
(1)
20
SMOOTH, durable, and
where
21
(2)
22
EASILY CLEANABLE
FOOD ESTABLISHMENT operations
Closely woven and
EASILY CLEANABLE
(3)
carpet for
Non absorbent for areas subject to moisture such
24
as
25
WAREWASHING
26
ESTABLISHMENT SERVICING AREAS,
27
flushing or spray cleaning methods.
29
are conducted;
carpeted areas; and
23
28
for areas
(B)
FOOD
preparation areas, walk-in refrigerators,
areas, toilet rooms, mobile
FOOD
and areas subject to
In a TEMPORARY FOOD ESTABLISHMENT:
(1)
If
graded
176
to
drain,
a
floor may
be concrete,
1
04.05.11
machine-laid asphalt, or dirt or gravel if it is
2
covered
3
duckboards, or other
4
effectively treated to control dust and mud; and
5
(2)
with
mats,
removable
APPROVED
that
7
windblown dust and debris.
Outdoor Areas
9
6-102.11
(A)
materials that are
Walls and ceilings may be constructed of a material
6
8
platforms,
protects
the interior
from the weather and
Surface Characteristics.
The outdoor walking and driving areas shall be surfaced
10
with concrete, asphalt, or gravel or other materials that
11
have been effectively treated to minimize dust, facilitate
12
maintenance, and prevent muddy conditions.
13
(B)
Exterior surfaces of buildings and mobile FOOD ESTABLISHMENTS
14
shall be of weather-resistant materials and shall comply
15
with
16
(C)
LAW .
Outdoor storage areas
17
returnables
shall
be
18
5-501.11 and 5-501.12.
for
of
REFUSE,
recyclables, or
materials specified under §§
19
20
6-2
DESIGN, CONSTRUCTION, AND INSTALLATION
Subparts
21
22
6-201
Cleanability
23
6-202
Functionality
6-201.11
Floors, Walls, and Ceilings.
24
Cleanability
25
Except as specified under § 6-201.14 and except for antislip
26
floor
27
reasons, floors, floor coverings, walls, wall coverings, and ceilings
28
shall
29
SMOOTH
30
6-201.12
coverings
or
applications that may be used for safety
be designed, constructed, and installed so they are
and
EASILY CLEANABLE.
Floors, Walls, and Ceilings, Utility Lines.
177
1
(A)
2
3
04.05.11
Utility service lines and pipes may not be unnecessarily
exposed
(B)
Exposed utility service lines and pipes shall be installed
4
so they do not obstruct or prevent cleaning of the floors,
5
walls, or ceilings.
6
(C)
7
8
Exposed horizontal utility service lines and pipes may not
be installed on the floor.
6-201.13
Floor and Wall Junctures, Coved, and Enclosed
9
10
or Sealed.
(A)
In
FOOD ESTABLISHMENTS in which cleaning methods other than
11
water flushing are used for cleaning floors, the floor and
12
wall junctures shall be coved and closed to no larger
13
than 1 mm (one thirty-second inch).
14
(B)
The floors in
FOOD ESTABLISHMENTS
in which water flush
15
cleaning methods are used shall be provided with drains
16
and be graded to drain, and the floor and wall junctures
17
shall be coved and
18
6-201.14
19
(A)
SEALED.
Floor Carpeting, Restrictions and Installation.
A floor covering such as carpeting
or similar material
20
may
21
preparation
22
areas, toilet room areas where handwashing lavatories,
23
toilets, and urinals are located,
24
other areas where the floor is subject to moisture,
25
flushing, or spray cleaning methods.
26
(B)
not
be
installed
areas,
as a
walk-in
floor covering
refrigerators,
REFUSE
in
FOOD
WAREWASHING
storage rooms, or
If carpeting is installed as a floor covering in areas other
27
than those specified under ¶ (A) of this section, it shall
28
be:
29
(1)
30
Securely attached to the floor with a durable
mastic, by using a stretch and tack method, or by
178
04.05.11
1
another method; and
2
(2)
Installed tightly against the wall under the coving or
3
installed away from the wall with a space between
4
the carpet and the wall and with the edges of the
5
carpet secured by metal stripping
6
means.
or some other
7
6-201.15
8
Mats and duckboards shall be designed to be removable and
9
EASILY CLEANABLE.
10
6-201.16
11
(A)
Floor Covering, Mats and Duckboards.
Wall and Ceiling Coverings and Coatings.
Wall and ceiling covering materials shall be attached so
that they are
12
13
(B)
EASILY CLEANABLE.
Except in areas used only for dry storage, concrete,
14
porous blocks, or bricks used for indoor wall construction
15
shall be finished and
16
nonabsorbent,
17
6-201.17
18
(A)
SEALED
EASILY CLEANABLE
to provide a
SMOOTH,
surface.
Walls and Ceilings, Attachments.
Except as specified in ¶ (B) of this section, attachments
19
to walls and ceilings such as light fixtures, mechanical
20
room ventilation system components, vent covers, wall
21
mounted fans, decorative items, and other attachments
22
shall be
23
(B)
In
a
EASILY CLEANABLE.
CONSUMER
area, wall and ceiling surfaces and
24
decorative items and attachments that are provided for
25
ambiance need not meet this requirement if they are kept
26
clean.
27
6-201.18
Walls and Ceilings, Studs, Joists, and Rafters.
28
Except for
TEMPORARY FOOD ESTABLISHMENTS,
29
rafters may not be exposed in areas subject to moisture.
30
Functionality
6-202.11
studs, joists, and
Light Bulbs, Protective Shielding.
179
1
(A)
04.05.11
Except as specified in ¶ (B) of this section, light bulbs
2
shall be shielded, coated, or otherwise shatter-resistant in
3
areas where there is exposed
4
UTENSILS,
5
SINGLE-USE ARTICLES.
6
(B)
and
LINENS;
FOOD;
or unwrapped
clean
EQUIPMENT,
SINGLE-SERVICE
and
Shielded, coated, or otherwise shatter-resistant bulbs need
7
not be used
in
areas
8
unopened packages, if:
9
(1)
used
only
for storing
FOOD
in
The integrity of the packages cannot be affected
10
by broken glass falling onto them; and
11
(2)
The packages are capable of being cleaned of
12
debris from broken bulbs before the packages are
13
opened.
14
(C)
An infrared or other heat lamp shall
be
protected
15
against breakage by a shield surrounding and extending
16
beyond the bulb so that only the face of the bulb is
17
exposed.
18
6-202.12
Heating,
19
Ventilating, Air Conditioning System
Vents.
20
Heating,
21
designed and installed so that make-up air intake and exhaust
22
vents do not cause contamination of FOOD, FOOD-CONTACT SURFACES,
23
ventilating,
EQUIPMENT,
24
6-202.13
25
(A)
or
and
air
conditioning
systems shall be
UTENSILS.
Insect Control Devices, Design and Installation.
Insect control devices that are used to electrocute or stun
26
flying insects shall be designed to retain the insect within
27
the device.
28
29
30
(B)
Insect control devices shall be installed so that:
(1)
The devices
are
not
preparation area; and
180
located
over
a
FOOD
1
(2)
04.05.11
Dead insects and insect fragments are prevented
2
from being impelled onto or falling on exposed
3
FOOD;
4
unwrapped
clean
EQUIPMENT, UTENSILS,
SINGLE-SERVICE
and
and
LINENS;
and
SINGLE-USE ARTICLES.
5
6-202.14
Toilet Rooms, Enclosed.
6
Except where a toilet room is located outside a
7
and does not open directly into the
8
toilet room that is provided by the management of a shopping mall, a
9
toilet room located on the
PREMISES
FOOD ESTABLISHMENT
FOOD ESTABLISHMENT
shall be completely enclosed
10
and provided with a tight-fitting and self-closing door.
11
6-202.15
12
(A)
Outer Openings, Protected.
Except as specified in ¶¶ (B), (C), and (E) and under ¶
13
(D) of
14
ESTABLISHMENT
15
insects and rodents by:
16
(1)
17
this
section,
outer
openings
of
a
FOOD
shall be protected against the entry of
Filling or closing holes and other gaps along
floors, walls, and ceilings;
18
(2)
Closed, tight-fitting windows; and
19
(3)
Solid, self-closing, tight-fitting doors.
20
such as a
(B)
Paragraph (A) of this section does not apply if a
FOOD
21
ESTABLISHMENT
22
mall,
23
structure, such as a porch, and the outer openings from
24
the larger or attached structure are protected against the
25
entry of insects and rodents.
26
(C)
opens into a larger structure, such as a
airport, or
office
building, or into
an
attached
Exterior doors used as exits need not be self-closing if
27
they are:
28
(1)
Solid and tight-fitting;
29
(2)
Designated for use only when an emergency exists,
30
by the fire protection authority that has jurisdiction
181
04.05.11
1
over the
2
(3)
FOOD ESTABLISHMENT;
and
Limited-use so they are not used for entrance or
3
exit from the building for purposes other than the
4
designated emergency exit use.
5
(D)
Except as specified in ¶¶ (B) and (E) of this section, if the
6
windows or doors of a
7
larger
8
located, are kept open for ventilation or other purposes
9
or a
structure
within
FOOD
ESTABLISHMENT,
which a
or of a
FOOD ESTABLISHMENT
TEMPORARY FOOD ESTABLISHMENT
is
is not provided with
10
windows
11
section, the openings shall
12
entry of insects and rodents by:
13
(1)
16 mesh to 25.4 mm (16 mesh to 1 inch) screens;
14
(2)
Properly designed and installed air curtains to
15
(3)
(E)
against the
Other effective means.
Paragraph (D) of this section does not apply if flying insects
18
19
be protected
control flying insects; or
16
17
and doors as specified under ¶ (A) of this
and other pests are absent due to the location of the
the weather, or other limiting condition.
ESTABLISHMENT,
20
6-202.16
Exterior Walls and Roofs, Protective Barrier.
21
Perimeter walls and roofs of a FOOD ESTABLISHMENT shall effectively
22
protect the establishment from the weather and the entry of
23
insects, rodents, and other animals.
24
6-202.17
25
Except for machines
26
outside, a machine used to vend
27
overhead protection.
28
6-202.18
29
Except
30
discharge of
Outdoor Food Vending Areas, Overhead Protection.
that
vend
canned
FOOD
BEVERAGES,
if located
shall be provided with
Outdoor Servicing Areas, Overhead Protection.
for
areas
used
SEWAGE
only for the loading of water or the
and other liquid waste, through the use of
182
1
a closed system of hoses,
2
with overhead protection.
3
6-202.19
SERVICING AREAS
04.05.11
shall be provided
Outdoor Walking and Driving Surfaces, Graded
4
to Drain.
5
Exterior walking and driving surfaces shall be graded to drain.
6
6-202.110
Outdoor Refuse Areas, Curbed and Graded to
7
Drain.
8
Outdoor
REFUSE
9
with
and shall be curbed and graded to drain to collect
LAW
areas
shall be constructed in accordance
10
and dispose of liquid waste that results from the
11
from cleaning the area and waste receptacles.
12
6-202.111
REFUSE
and
Private Homes and Living or Sleeping Quarters,
Use Prohibition.
13
14
A private home, a room used as living or sleeping quarters, or
15
an area directly opening into a room used as living or sleeping
16
quarters shall not be used for conducting
17
operations.
18
6-202.112
19
Living or sleeping quarters located on the
20
ESTABLISHMENT
21
clerks or resident managers shall be separated from rooms and
22
areas used for
23
partitioning and solid self-closing doors.
FOOD ESTABLISHMENT
Living or Sleeping Quarters, Separation.
PREMISES
of a
FOOD
such as those provided for lodging registration
FOOD
ESTABLISHMENT
24
183
operations by complete
04.05.11
1
6-3
NUMBERS AND CAPACITIES
Subparts
2
3
6-301
Handwashing Sinks
4
6-302
Toilets and Urinals
5
6-303
Lighting
6
6-304
Ventilation
7
6-305
Dressing Areas and Lockers
8
6-306
Service Sinks
Minimum Number.
9
10
Handwashing
6-301.10
11
Sinks
HANDWASHING
shall
SINKS
be
provided
as specified under
12
§ 5-203.11.
13
6-301.11
14
Each
HANDWASHING SINK
15
SINKS
shall be provided with a supply of hand cleaning liquid
16
or powder soap.
17
6-301.12
18
Each
19
shall be provided with:
20
(A)
Individual, disposable towels;
21
(B)
A continuous towel system that supplies the user with a
22
Handwashing Cleanser, Availability.
or group of 2 adjacent
HANDWASHING
Hand Drying Provision.
HANDWASHING SINK
or group of adjacent
HANDWASHING SINKS
clean towel; or
23
(C)
A heated-air hand drying device.
24
6-301.13
25
A sink used for
26
service sink or curbed cleaning facility used for the disposal of
27
mop water or similar wastes,
28
handwashing aids and devices required for a
29
as specified under §§ 6-301.11 and 6-301.12 and ¶ 5-501.16(C).
30
6-301.14
Handwashing Aids and Devices, Use Restrictions.
FOOD
preparation or
washing, or a
shall not be provided with the
Handwashing Signage.
184
UTENSIL
HANDWASHING SINK
04.05.11
to wash their
1
A sign or poster that notifies
FOOD EMPLOYEES
2
hands shall be provided at all
HANDWASHING SINKS
3
EMPLOYEES
4
6-301.20
5
A
6
that is provided with disposable towels shall be provided with a
7
waste receptacle as specified under ¶ 5-501.16(C).
and shall be clearly visible to
Toilets and
6-302.10
9
Urinals
Toilets
FOOD
FOOD EMPLOYEES.
Disposable Towels, Waste Receptacle.
or group of adjacent
HANDWASHING SINK
8
used by
HANDWASHING SINKS
Minimum Number.
and
urinals
shall
be
provided
as
specified under
10
§ 5-203.12
11
6-302.11
12
A supply of toilet tissue shall be available at each toilet and
13
shall be provided to the user in a manner that minimizes its
14
contamination
15
contamination.
16
Lighting
6-303.11
Toilet Tissue, Availability.
from
dust,
water,
and
other
types
of
Intensity.
17
The light intensity shall be:
18
(A)
At least 108 lux (10 foot candles) at a distance of 75 cm
19
(30 inches) above the floor, in walk-in refrigeration units
20
and dry
21
rooms during periods of cleaning;
22
23
(B)
FOOD
storage areas and in other areas and
At least 215 lux (20 foot candles):
(1)
At a surface where
FOOD
is provided for
CONSUMER
24
self-service such as buffets and salad bars or
25
where fresh produce or
26
or offered for consumption,
27
(2)
30
EQUIPMENT
are sold
such as reach-in and under-
counter refrigerators; and
28
29
Inside
PACKAGED FOODS
(3)
At a distance of 75 cm (30 inches) above the floor
in areas used for handwashing,
185
WAREWASHING,
and
1
EQUIPMENT
2
and
3
(C)
FOOD EMPLOYEE
5
UTENSILS
6
or saws where
Ventilation
UTENSIL
04.05.11
storage, and in toilet rooms;
At least 540 lux (50 foot candles) at a surface where a
4
7
and
6-304.11
or
is working with
EQUIPMENT
FOOD
or working with
such as knives, slicers, grinders,
EMPLOYEE
safety is a factor.
Mechanical.
8
If necessary to keep rooms free of excessive heat, steam,
9
condensation, vapors, obnoxious odors, smoke, and fumes,
10
mechanical ventilation of sufficient capacity shall be provided.
11
Dressing Areas
6-305.11
12
and
(A)
13
Lockers
Designation.
Dressing rooms or dressing areas shall be designated
if EMPLOYEES routinely change their clothes in the
14
establishment.
15
(B)
Lockers or other suitable facilities shall be provided for
16
the orderly
17
possessions.
18
Service Sinks
6-306.10
storage
of
EMPLOYEES'
clothing and other
Availability.
19
A service sink or curbed cleaning facility shall be provided as
20
specified under § 5-203.13.
21
22
23
6-4
LOCATION AND PLACEMENT
Subparts
24
6-401
Handwashing Sinks
25
6-402
Toilet Rooms
26
6-403
Employee Accommodations
27
6-404
Distressed Merchandise
28
6-405
Refuse, Recyclables, and Returnables
6-401.10
Conveniently Located.
186
29
30
Handwashing
1
Sinks
HANDWASHING
2
3
04.05.11
shall be conveniently located as specified
SINKS
under § 5-204.11.
Toilet Rooms
6-402.11
Convenience and Accessibility.
4
Toilet rooms shall be conveniently located and accessible to
5
EMPLOYEES
6
Employee
7
Accommodations (A)
6-403.11
during all hours of operation.
Designated Areas.
Areas designated for
EMPLOYEES
8
tobacco shall be located so that
9
SINGLE-SERVICE
10
contamination.
11
(B)
and
to eat, drink, and use
FOOD, EQUIPMENT, LINENS, and
SINGLE-USE ARTICLES
are protected from
Lockers or other suitable facilities shall be located in a
12
designated
13
EQUIPMENT, UTENSILS, LINENS,
14
USE ARTICLES
15
Distressed
6-404.11
16
Merchandise
Products
room or area where contamination of
FOOD,
and SINGLE-SERVICE and SINGLE-
cannot occur.
Segregation and Location.
that
are
held
by
the
PERMIT HOLDER
for credit,
17
redemption, or return to the distributor, such as damaged,
18
spoiled, or recalled products, shall be segregated and held in
19
designated areas that are separated from
20
UTENSILS, LINENS,
and
SINGLE-SERVICE
and
FOOD, EQUIPMENT,
SINGLE-USE ARTICLES.
21
Refuse,
22
Recyclables,
23
and
Units,
receptacles,
24
Returnables
REFUSE
and recyclable and returnable containers shall be
25
6-405.10
Receptacles,
Waste
Handling
Units,
and
Designated Storage Areas.
and
areas designated for storage of
located under as specified § 5-501.19.
26
27
6-5
Subpart
28
29
30
MAINTENANCE AND OPERATION
6-501 Premises, Structures, Attachments, and Fixtures– Methods
Premises,
6-501.11
Repairing.
187
1
Structures,
2
Attachments,
3
and Fixtures
4
- Methods
04.05.11
PHYSICAL
5
6-501.12
6
(A)
7
8
FACILITIES
shall be maintained in good repair.
Cleaning, Frequency and Restrictions.
PHYSICAL
FACILITIES
shall
be
cleaned
as
often
as
necessary to keep them clean.
(B)
Except for cleaning that is necessary due to a spill or
other accident, cleaning shall be done during periods
9
10
when the least amount
11
after closing.
12
6-501.13
13
(A)
of
FOOD
is exposed such as
Cleaning Floors, Dustless Methods.
Except
as specified
in ¶ (B) of
this section, only
14
dustless methods of cleaning shall be used, such as wet
15
cleaning, vacuum cleaning, mopping with treated dust
16
mops, or sweeping using a broom and dust-arresting
17
compounds.
18
(B)
Spills or drippage on floors that occur between normal
19
floor cleaning times may be cleaned:
20
(1)
Without the use of dust-arresting compounds; and
21
(2)
In the case of liquid spills or drippage, with the use
22
of a small amount of absorbent compound such as
23
sawdust or diatomaceous earth applied immediately
24
before spot cleaning.
25
6-501.14
26
27
Cleaning
Ventilation
Systems,
Nuisance
and
Discharge Prohibition.
(A)
Intake and exhaust air ducts shall be cleaned and filters
28
changed so they are not a source of contamination by
29
dust, dirt, and other materials.
30
(B)
If vented to the outside, ventilation systems shall not
188
1
create a public health
2
discharge.
3
6-501.15
4
Cleaning
HAZARD
04.05.11
or nuisance or unLAWful
Maintenance
Tools,
Preventing
Contamination.*
5
FOOD preparation sinks,
HANDWASHING SINKS,
and
6
EQUIPMENT
7
tools, the preparation or holding of maintenance materials, or
8
the disposal of mop water and similar liquid wastes.
9
6-501.16
WAREWASHING
shall not be used for the cleaning of maintenance
Drying Mops.
10
After use, mops shall be placed in a position that allows them
11
to air-dry without soiling walls,
12
6-501.17
13
Except as specified in ¶ 6-501.13(B), sawdust, wood shavings,
14
granular
15
materials shall not be used on floors.
16
6-501.18
17
PLUMBING
18
shall be cleaned as often as necessary to keep them clean and
19
maintained and used as specified under § 5-205.11.
20
6-501.19
21
Except during cleaning and maintenance operations, toilet room
22
doors as specified under § 6-202.14 shall be kept closed.
23
6-501.110
24
(A)
salt,
baked
FIXTURES
such as
diatomaceous
earth,
or similar
HANDWASHING SINKS, toilets, and urinals
Closing Toilet Room Doors.
Using Dressing Rooms and Lockers.
Dressing rooms shall be used by
26
establishment.
regularly
change
their
EMPLOYEES
clothes
if the
in
the
Lockers or other suitable facilities shall be used for the
28
orderly storage
29
possessions.
30
clay,
Cleaning of Plumbing Fixtures.
EMPLOYEES
(B)
or supplies.
Absorbent Materials on Floors, Use Limitation.
25
27
EQUIPMENT,
6-501.111
of
EMPLOYEE
Controlling Pests.*
189
clothing
and
other
presence
of
04.05.11
insects, rodents, and other pests shall be
1
The
2
controlled to minimize their presence on the
3
(A)
PREMISES
Routinely inspecting incoming shipments of
by:
and
FOOD
supplies;N
4
for evidence of pests;N
5
(B)
Routinely inspecting the
6
(C)
Using methods, if pests are found, such as trapping
PREMISES
7
devices
8
under §§ 7-202.12, 7-206.12, and 7-206.13; and
9
10
(D)
or other means of pest control as specified
Eliminating harborage conditions.N
6-501.112
11
Removing
Dead or Trapped Birds, Insects,
Rodents, and Other Pests.
12
Dead or trapped birds, insects, rodents, and other pests shall
13
be
14
frequency that prevents their accumulation, decomposition, or
15
the attraction of pests.
16
6-501.113
17
Maintenance tools such
18
and similar items shall be:
19
(A)
20
21
(B)
from control devices and
the
PREMISES
at
a
Storing Maintenance Tools.
as brooms, mops, vacuum cleaners,
Stored so they do not contaminate FOOD, EQUIPMENT, UTENSILS,
LINENS,
22
23
removed
and SINGLE-SERVICE and SINGLE-USE
ARTICLES;
and
Stored in an orderly manner that facilitates cleaning the
area used for storing the maintenance tools.
6-501.114.1.1
Maintaining Premises, Unnecessary Items
24
and Litter.
25
The
PREMISES
26
(A)
Items
shall be free of:
that
are
unnecessary to the
operation
27
maintenance of the
28
that is nonfunctional or no longer used; and
29
(B)
30
6-501.115
establishment such as
Litter.
Prohibiting Animals.*
190
or
EQUIPMENT
1
(A)
04.05.11
Except as specified in ¶¶ (B) and (C) of this section, live
2
animals shall not be allowed on the
3
ESTABLISHMENT.
4
5
(B)
of a
FOOD
Live animals may be allowed in the following situations if
the contamination of
6
LINENS;
7
ARTICLES
8
(1)
9
FOOD;
and unwrapped
clean
EQUIPMENT, UTENSILS,
SINGLE-SERVICE
and
and
SINGLE-USE
in
aquariums,
cannot result.
Edible
or
FISH
decorative
FISH
shellfish or crustacea on ice or under refrigeration,
10
and
11
systems;
12
PREMISES
(2)
Patrol
shellfish
dogs
and
crustacea
in
accompanying
display
police
or
tank
security
13
officers in offices and dining, sales,
14
areas, and sentry dogs running loose in outside
15
fenced areas;
16
(3)
In areas that are not used for
and storage
FOOD
preparation
17
and that are usually open for customers, such as
18
dining
19
controlled by the disabled
20
health or safety
21
presence or activities of the
22
(4)
and sales areas,
HAZARD
SERVICE ANIMALS
EMPLOYEE
will
or
that are
PERSON,
if a
not result from the
SERVICE ANIMAL;
Pets in the common dining areas of institutional
23
care facilities such as nursing homes, assisted
24
living
25
facilities at times other than during meals if:
26
(a)
facilities, group homes, or residential care
Effective partitioning and self-closing doors
27
separate
28
FOOD
29
30
(b)
the common dining areas from
storage or
Condiments,
FOOD
preparation areas,
EQUIPMENT,
and
UTENSILS
are
stored in enclosed cabinets or removed from
191
04.05.11
common dining areas when pets are
1
the
2
present, and
3
(c)
Dining areas including tables, countertops,
4
and similar surfaces are effectively cleaned
5
before the next meal service; and
6
(5)
In areas that are not used for
FOOD
preparation,
7
storage, sales, display, or dining, in which there
8
are caged animals or animals that are similarly
9
confined, such as in a variety store that sells pets
10
11
12
13
or a tourist park that displays animals.
(C)
Live or dead
FOOD;
clean
FISH
bait may be stored if contamination of
EQUIPMENT, UTENSILS, and LINENS; and unwrapped
SINGLE-SERVICE
and
192
SINGLE-USE ARTICLES
cannot result.
04.05.11
1
Chapter
2
7
3
Parts
Poisonous or Toxic Materials
4
7-1
LABELING AND IDENTIFICATION
5
7-2
OPERATIONAL SUPPLIES AND APPLICATIONS
6
7-3
STOCK AND RETAIL SALE
7-1
LABELING AND IDENTIFICATION
7
8
9
Subparts
10
7-101
Original Containers
11
7-102
Working Containers
Identifying Information, Prominence.*
12
13
Original
7-101.11
14
Containers
Containers of POISONOUS OR TOXIC MATERIALS and PERSONAL CARE ITEMS
15
shall bear a legible manufacturer's label.
16
Working
7-102.11
Common Name.*
17
Containers
Working containers
for
OR
TOXIC
19
supplies shall be clearly and individually identified with the common
20
name of the material.
22
and
POISONOUS
MATERIALS
7-2
as cleaners
storing
18
21
such
used
SANITIZERS
OPERATIONAL SUPPLIES AND APPLICATIONS
Subparts
23
7-201
Storage
24
7-202
Presence and Use
25
7-203
Container Prohibitions
26
7-204
Chemicals
27
7-205
Lubricants
28
7-206
Pesticides
193
taken from bulk
04.05.11
1
7-207
Medicines
2
7-208
First Aid Supplies
3
7-209
Other Personal Care Items
7-201.11
Separation.*
4
5
Storage
6
POISONOUS
7
contaminate FOOD, EQUIPMENT, UTENSILS, LINENS, and SINGLE-SERVICE
8
and SINGLE-USE ARTICLES by:
9
(A)
OR TOXIC MATERIALS
Separating the
shall be stored so they can not
POISONOUS OR TOXIC MATERIALS
by spacing or
partitioning;S and
10
11
(B)
Locating the
POISONOUS OR TOXIC MATERIALS
12
that is not above
13
SINGLE-SERVICE
14
not apply to
15
that are stored in
16
convenience
17
contamination of
18
SINGLE-SERVICE
FOOD, EQUIPMENT, UTENSILS, LINENS,
EQUIPMENT
if
and
UTENSIL
the
cleaners and SANITIZERS
areas for availability and
WAREWASHING
materials are
stored
to prevent
FOOD, EQUIPMENT, UTENSILS, LINENS,
and
Presence and
7-202.11
Restriction.*
20
Use
(A)
those
POISONOUS
OR
TOXIC
MATERIALS
that
required for the operation and maintenance of a
22
ESTABLISHMENT,
23
EQUIPMENT
24
rodents, shall be allowed in a
(B)
26
UTENSILS
28
POISONOUS
FOOD ESTABLISHMENT.
29
(A)
shall be:
Used according to:
(1)
LAW and this Code,
194
of
S
PACKAGED
that are for retail sale.
Conditions of Use.*
OR TOXIC MATERIALS
FOOD
and the control of insects and
POISONOUS OR TOXIC MATERIALS
7-202.12
are
SANITIZING
Paragraph (A) of this section does not apply to
27
30
such as for the cleaning and
and
and
SINGLE-USE ARTICLES.
21
25
and
or SINGLE-USE ARTICLES. This paragraph does
19
Only
in an area
1
04.05.11
Manufacturer's use directions included in labeling, and,
(2)
2
for a pesticide, manufacturer's label instructions that
3
state that use is allowed in a
4
(3)
The
5
FOOD ESTABLISHMENT,
conditions of certification, if certification is
required, for use of the pest control materials, and
6
(4)
Additional conditions that may be established by the
7
REGULATORY AUTHORITY;
8
(B)
9
and
Applied so that:
(1)
A
10
to
HAZARD
EMPLOYEES
or other
PERSONS
is not
constituted, and
11
(2)
Contamination including toxic residues due to drip,
12
drain, fog, splash or spray on
13
UTENSILS, LINENS,
14
ARTICLES
is prevented, and for a
15
PESTICIDE,
this is achieved by:
16
(a)
Removing the items,
17
(b)
Covering the items with impermeable covers,
18
and
FOOD, EQUIPMENT,
SINGLE-SERVICE
and
SINGLE-USE
RESTRICTED USE
or
19
(c)
20
Taking other appropriate preventive actions,
and
21
(d)
22
Cleaning and SANITIZING EQUIPMENT and UTENSILS
after the application.
23
C)
A
RESTRICTED USE PESTICIDE
shall be applied only by an
24
applicator certified as defined in 7 USC 136 Definitions, (e)
25
Certified Applicator, of the Federal Insecticide, Fungicide,
26
and
27
supervision of a certified applicator.
Rodenticide
Act, or a
28
Container
7-203.11
29
Prohibitions
A container previously used to store
30
PERSON
under the direct
Poisonous or Toxic Material Containers.*
POISONOUS OR TOXIC MATERIALS
may not be used to store, transport, or dispense FOOD.
195
04.05.11
1
Chemicals
7-204.11
Sanitizers, Criteria.*
2
Chemical
3
FOOD-CONTACT SURFACEs
4
40 CFR 180.940 Tolerance exemptions for active and inert
5
ingredients for use in
6
surface sanitizing solutions).
7
7-204.12
SANITIZERS
8
and other chemical antimicrobials applied to
shall meet the requirements specified in
antimicrobial
formulations (food-contact
Chemicals for Washing Fruits and Vegetables,
Criteria.*
9
Chemicals used to wash or peel raw, whole fruits and vegetables
10
shall meet the requirements specified in 21 CFR 173.315 Chemicals
11
used
12
vegetables.
13
7-204.13
14
Chemicals used
15
requirements specified in 21 CFR 173.310 Boiler water additives.
16
7-204.14
17
Drying agents used in conjunction with
18
(A)
in
washing
or
to
assist in the peeling of fruits and
Boiler Water Additives, Criteria.*
as boiler water
ADDITIVES
shall meet the
Drying Agents, Criteria.*
SANITIZATION
shall:
Contain only components that are listed as one of the
19
following:
20
(1)
Generally recognized as safe for use in
FOOD
as
21
specified in 21 CFR 182 - Substances Generally
22
Recognized as Safe, or 21 CFR 184 - Direct Food
23
Substances
24
Safe,
25
(2)
Generally recognized as safe for the intended use
26
as
27
Substances
28
Safe,
29
30
(3)
Affirmed as Generally Recognized as
specified
in
21 CFR 186 - Indirect Food
Affirmed as Generally Recognized as
APPROVED for use as a drying agent under a prior
sanction specified in 21 CFR 181 - Prior-Sanctioned
196
04.05.11
1
Food Ingredients,
2
(4)
Specifically regulated as an indirect
FOOD ADDITIVE
3
for use as a drying agent as specified in 21 CFR
4
Parts 175-178, or
5
(5)
APPROVED
for use as a drying agent under the
6
threshold of regulation process established by 21
7
CFR 170.39 Threshold of regulation for substances
8
used in food-contact articles; and
9
(B)
When
SANITIZATION
is with chemicals, the approval required
10
under Subparagraph (A)(3) or (A)(5) of this section or the
11
regulation as an indirect
12
Subparagraph (A)(4) of this section, shall be specifically for
13
use with chemical
14
Lubricants
7-205.11
FOOD ADDITIVE
SANITIZING
required under
solutions.
Incidental Food Contact, Criteria.*
15
Lubricants shall meet
16
178.3570 Lubricants with incidental food contact, if they are used
17
on
18
within
19
located so that lubricants may leak, drip, or be forced into
20
onto
21
Pesticides
the
FOOD-CONTACT SURFACES,
requirements specified in 21 CFR
on bearings and gears located on or
FOOD-CONTACT SURFACES,
or on bearings and gears that are
FOOD
or
FOOD-CONTACT SURFACES.
7-206.11
Restricted Use Pesticides, Criteria.*
22
RESTRICTED USE PESTICIDES specified under ¶ 7-202.12(C) shall meet
23
the
24
Classification of Pesticides.
25
7-206.12
26
Rodent bait shall be contained in a covered, tamper-resistant bait
27
station.
28
7-206.13
29
(A)
30
requirements
specified
in
40 CFR 152
Subpart I -
Rodent Bait Stations.*
Tracking Powders, Pest Control and Monitoring.*
Except as specified in ¶ (B) of this section, a tracking
powder pesticide
197
may
not be used
in
a
FOOD
04.05.11
1
ESTABLISHMENT.
2
(B)
If used, a nontoxic tracking powder such as talcum or flour
3
may not contaminate FOOD, EQUIPMENT, UTENSILS, LINENS, and
4
SINGLE-SERVICE
5
Medicines
6
7-207.11
(A)
and
SINGLE-USE ARTICLES.
N
Restriction and Storage.*
Except for medicines that are stored or displayed for retail
7
sale, only those medicines that are necessary for the
8
health
9
ESTABLISHMENT.
10
(B)
of
EMPLOYEES
shall be allowed in a
Medicines
that are in a
11
EMPLOYEES'
use
12
7-101.11 and located to prevent the contamination of
13
EQUIPMENT, UTENSILS, LINENS,
14
USE ARTICLES.
15
7-207.12
16
Medicines belonging to
17
center
18
refrigerator shall be:
19
(A)
FOOD ESTABLISHMENT
FOOD,
and SINGLE-SERVICE and SINGLE-
Refrigerated Medicines, Storage.*
that
require
EMPLOYEES
refrigeration
or to children in a day care
and are stored in a
FOOD
Stored in a package or container and kept inside a
covered,
21
container for the storage of medicines; and
(B)
for the
shall be labeled as specified under §
20
22
FOOD
leakproof
container that
is
identified
as
a
Located so they are inaccessible to children.
23
First Aid
7-208.11
Storage.*
24
Supplies
First aid
supplies that are in a
25
EMPLOYEES'
use shall be:
26
(A)
Labeled as specified under § 7-101.11;S and
27
(B)
Stored in a kit or a container that is located to prevent the
FOOD ESTABLISHMENT
for the
28
contamination of FOOD, EQUIPMENT, UTENSILS, and LINENS, and
29
SINGLE-SERVICE
30
Other Personal
7-209.11
and
Storage.
198
SINGLE-USE ARTICLES.
S
04.05.11
1
Care Items
Except as specified under §§ 7-207.12 and 7-208.11,
2
shall store their
3
¶ 6-305.11(B).
4
7-3
5
PERSONAL CARE ITEMS
EMPLOYEES
in facilities as specified under
STOCK AND RETAIL SALE
Subpart
6
7-301
Storage and Display
Separation.*
7
8
Storage and
7-301.11
9
Display
POISONOUS or
TOXIC MATERIALS
shall be stored and displayed for
10
retail sale so they can not contaminate
11
LINENS,
12
(A)
Separating the
SINGLE-USE ARTICLES
POISONOUS
or
TOXIC MATERIALS
by:
by spacing or
partitioning;S and
13
14
and SINGLE-SERVICE and
FOOD, EQUIPMENT, UTENSILS,
(B)
Locating the
POISONOUS OR TOXIC MATERIALS
in an area
15
that is not above
FOOD, EQUIPMENT, UTENSILS, LINENS,
16
SINGLE-SERVICE
SINGLE-USE ARTICLES.
or
17
18
19
20
21
22
23
24
25
26
27
28
199
and
04.05.11
1
2
3
INTENTIONALLY LEFT BLANK
4
5
6
7
8
200
04.05.11
1
Chapter
2
8
3
Parts
Compliance and Enforcement
4
8-1
CODE APPLICABILITY
5
8-2
PLAN SUBMISSION AND APPROVAL
6
8-3
PERMIT TO OPERATE
7
8-4
INSPECTION AND CORRECTION OF VIOLATIONS
8
8-5
PREVENTION OF FOODBORNE DISEASE TRANSMISSION BY
9
EMPLOYEES
10
11
8-1
12
CODE APPLICABILITY
Subparts
13
8-101
Use for Intended Purpose
14
8-102
Additional Requirements
15
8-103
Variances
16
17
Use for
8-101.10
Public Health Protection.
18
Intended
(A)
REGULATORY
19
Purpose
The
shall
AUTHORITY
apply this Code to
promote its underlying purpose, as specified in §1-102.10,
20
of safeguarding public health and ensuring that
21
safe,
22
offered to the
23
(B)
unADULTERATED,
and
honestly
FOOD
presented
is
when
CONSUMER.
In enforcing the provisions of this Code, the
24
AUTHORITY
25
were in use before the effective date of this Code based
26
on the following considerations:
27
(1)
28
shall assess existing facilities or
REGULATORY
Whether the facilities or
repair and
capable
201
of
EQUIPMENT
EQUIPMENT
being
that
are in good
maintained
in
a
1
04.05.11
sanitary condition;
2
(2)
Whether
3
FOOD-CONTACT SURFACES
comply
with
Subpart 4-101;
4
(3)
Whether the capacities of cooling, heating, and
5
holding
6
4-301.11; and
7
(4)
are sufficient to comply with §
EQUIPMENT
The existence of a documented agreement with the
8
PERMIT HOLDER
9
replaced as specified under ¶ 8-304.11(G) or upgraded
10
that the facilities or
EQUIPMENT
will be
or replaced as specified under ¶ 8-304.11(H).
11
Additional
12
Requirements
13
8-102.10
Preventing Health Hazards, Provision for
Conditions Not Addressed.
(A)
If necessary to protect against public health
HAZARDS
or
14
nuisances, the
15
requirements in addition to the requirements contained in
16
this Code that are authorized by
17
(B)
The
REGULATORY AUTHORITY
REGULATORY AUTHORITY shall
may impose specific
LAW .
document the conditions that
18
necessitate the imposition of additional requirements and
19
the underlying public health rationale. The documentation
20
shall be provided to the
21
and a copy shall be maintained in the REGULATORY AUTHORITY’S
22
file for the
23
Variances
8-103.10
PERMIT
applicant or
PERMIT HOLDER
FOOD ESTABLISHMENT.
Modifications and Waivers.
24
The
25
waiving the requirements of this Code if in the opinion of
26
REGULATORY AUTHORITY
27
from the
28
AUTHORITY
29
in its records for the
30
8-103.11
REGULATORY AUTHORITY
VARIANCE.
may grant a
VARIANCE
by modifying or
the
a health HAZARD or nuisance will not result
If a
VARIANCE
is granted, the
REGULATORY
shall retain the information specified under § 8-103.11
FOOD ESTABLISHMENT.
Documentation of
202
Proposed
Variance
and
04.05.11
1
Justification.
2
Before a
3
the information that shall be provided by the
4
the VARIANCE and retained in the
5
the
6
(A)
from a requirement of this Code is
FOOD ESTABLISHMENT
7
8
VARIANCE
requesting
REGULATORY AUTHORITY'S
file on
includes:
A statement of the proposed
of the Code
VARIANCE
requirement citing relevant Code section numbers;
(B)
An analysis of the rationale for how the potential public
9
health
10
Code
11
proposal; and
12
PERSON
APPROVED,
(C)
A
HAZARDS
and nuisances addressed by the relevant
sections
HACCP
will
be alternatively addressed by the
if
PLAN
required
as specified
under
13
¶ 8-201.13(A) that includes the information specified under
14
§ 8-201.14 as it is relevant to the
15
8-103.12
16
If the
17
§ 8-103.10, or a HACCP
18
under § 8-201.13, the
19
(A)
VARIANCE
Conformance with Approved Procedures.*
REGULATORY AUTHORITY
grants a
PLAN
VARIANCE
as specified in
is otherwise required as specified
PERMIT HOLDER
Comply with the HACCP
shall:
PLANs
and procedures that
20
submitted as specified under § 8-201.14 and
21
a basis for the modification or waiver; and
22
(B)
requested.
Maintain and provide to the
are
APPROVED
REGULATORY AUTHORITY,
as
upon
23
request, records specified under ¶¶ 8-201.14(D) and (E) that
24
demonstrate that the following are routinely employed;
25
(1)
Procedures for monitoring the CRITICAL CONTROL
26
(2)
Monitoring of the
27
(3)
Verification of the effectiveness of the operation or
28
29
30
POINTS,
CRITICAL CONTROL POINTS,
process, and
(4)
Necessary corrective actions if there is failure at a
CRITICAL CONTROL POINT.
203
04.05.11
1
2
8-2
3
PLAN SUBMISSION AND APPROVAL
Subparts
4
8-201
Facility and Operating Plans
5
8-202
Confidentiality
6
8-203
Construction Inspection and Approval
When Plans Are Required.
7
8
Facility and
8-201.11
9
Operating Plans
A
PERMIT
applicant or PERMIT HOLDER shall submit to the REGULATORY
10
AUTHORITY properly
11
approval before:
12
(A)
The construction of a
13
(B)
The conversion of an existing structure for use as a
14
15
prepared plans and specifications for review and
ESTABLISHMENT;
(C)
FOOD ESTABLISHMENT;
FOOD
or
The remodeling of a
FOOD ESTABLISHMENT
or a change of
16
type of
17
under ¶ 8-302.14(C) if the REGULATORY AUTHORITY determines
18
that plans and specifications are necessary to ensure
19
compliance with this Code.
FOOD ESTABLISHMENT
or
FOOD
operation as specified
20
8-201.12
21
The plans and specifications for a
22
a
23
required by the
24
operation, type of
25
following information to demonstrate conformance with Code
26
provisions:
27
(A)
Intended menu;
28
(B)
Anticipated volume of
FOOD ESTABLISHMENT
29
30
Contents of the Plans and Specifications.
FOOD ESTABLISHMENT,
including
specified under §8-201.13, shall include, as
REGULATORY AUTHORITY
FOOD
based on
preparation, and
FOOD
FOODS
the
type of
prepared, the
to be stored, prepared, and
sold or served;
(C)
Proposed layout, mechanical
204
schematics, construction
1
2
(D)
Proposed
EQUIPMENT
types, manufacturers, model numbers,
3
locations,
4
installation specifications;
5
04.05.11
materials, and finish schedules;
(E)
dimensions,
performance
capacities,
and
Evidence that standard procedures that ensure compliance
6
with the requirements of this Code are developed or are
7
being developed; and
8
(F)
9
Other information that may be required by the
AUTHORITY
REGULATORY
for the proper review of the proposed construction,
10
conversion or modification, and procedures for operating a
11
FOOD ESTABLISHMENT.
12
8-201.13
13
(A)
When a HACCP Plan is Required.
Before engaging in an activity that requires a HACCP
14
PLAN,
15
the
16
HACCP
17
relevant provisions of this Code if:
18
(1)
19
20
(2)
a
PERMIT
applicant or
REGULATORY AUTHORITY
PLAN
for approval a properly prepared
Submission of a HACCP
to
LAW ;
A
VARIANCE
is
Subparagraph
22
¶ 4-204.110(B);
(3)
The
shall submit to
as specified under § 8-201.14 and
21
23
PERMIT HOLDER
PLAN
required
is required according
as
3-401.11(D)(3),
REGULATORY AUTHORITY
the
specified
under
§ 3-502.11,
determines that a
or
FOOD
24
preparation or processing method requires a VARIANCE
25
based on a plan submittal specified under §
26
8-201.12, an inspectional finding, or a
27
request.
28
29
30
(B)
A
PERMIT
applicant or
prepared HACCP
8-201.14
PERMIT HOLDER
PLAN
shall have a properly
as specified under § 3-502.12.
Contents of a HACCP Plan.
205
VARIANCE
1
For a
2
have a HACCP
3
(A)
04.05.11
that is required under § 8-201.13 to
FOOD ESTABLISHMENT
PLAN,
the plan and specifications shall indicate:
A categorization of the types of POTENTIALLY HAZARDOUS FOODS
4
(TIME/TEMPERATURE
5
specified in the menu such as soups and sauces, salads,
6
and bulk, solid
7
FOODS
8
(B)
9
A
CONTROL FOR SAFETY FOODS)
FOODS
such as
that are specified by the
flow diagram
by
MEAT
that
roasts, or of other
REGULATORY AUTHORITY;
specific
or
FOOD
category type
identifying CRITICAL CONTROL POINTS and providing information
10
on the following:
11
(1)
12
Ingredients, materials, and
preparation of that
13
(2)
FOOD,
EQUIPMENT
used in the
and
Formulations or recipes that delineate methods and
14
procedural control measures that address the
15
safety concerns involved;
16
(C)
17
18
are
FOOD
EMPLOYEE
addresses the
(D)
and
FOOD
supervisory training
FOOD
plan
that
safety issues of concern;
A statement of standard operating procedures for the plan
19
under consideration including clearly identifying:
20
(1)
Each
21
(2)
The
22
(3)
The method and frequency for monitoring and
CRITICAL CONTROL POINT,
CRITICAL LIMITS
23
controlling each
24
EMPLOYEE
25
(4)
for each
CRITICAL CONTROL POINT,
CRITICAL CONTROL POINT
designated by the
by the
FOOD
PERSON IN CHARGE,
The method and frequency for the
26
to
27
following standard operating procedures and monitoring
28
29
30
routinely verify that the
PERSON IN CHARGE
FOOD
EMPLOYEE
is
CRITICAL CONTROL POINTS,
(5)
Action to be taken by the
CRITICAL LIMITS
206
for each
PERSON IN CHARGE
if the
CRITICAL CONTROL POINT
are
1
04.05.11
not met, and
2
(6)
Records to be maintained by the
3
to demonstrate that the HACCP
4
operated and managed; and
5
(E)
by the
7
that
Confidentiality
9
is properly
PLAN
Additional scientific data or other information, as required
6
8
PERSON IN CHARGE
FOOD
8-202.10
The
REGULATORY AUTHORITY, supporting
the determination
safety is not compromised by the proposal.
Trade Secrets.
REGULATORY
LAW ,
shall treat as confidential
accordance
11
specified
12
inspection report forms and in the plans and specifications
13
submitted as specified under §§ 8-201.12 and 8-201.14.
LAW
information
that
meets
the
in
10
in
with
AUTHORITY
criteria
for a trade secret and is contained on
14
Construction
8-203.10
15
Inspection
The
16
and Approval
operational inspections to verify that the
Preoperational Inspections.
REGULATORY AUTHORITY
shall
conduct one or more
pre-
FOOD ESTABLISHMENT
is
17
constructed and equipped in accordance with the
18
plans and
19
standard operating procedures as specified under ¶ 8-201.12(E),
20
and is in compliance with
APPROVED
APPROVED
modifications of those plans, has established
LAW
and this Code.
21
22
23
8-3
PERMIT TO OPERATE
Subparts
24
8-301
Requirement
25
8-302
Application Procedure
26
8-303
Issuance
27
8-304
Conditions of Retention
8-301.11
Prerequisite for Operation.
28
Requirement
29
A
30
PERMIT
PERSON
may not operate a
FOOD ESTABLISHMENT
to operate issued by the
207
without a valid
REGULATORY AUTHORITY.
1
Application
2
Procedure
8-302.11
04.05.11
Submission 30 Calendar Days Before Proposed
Opening.
3
An applicant shall submit an application for a
4
30 calendar days before the date planned for opening a
5
ESTABLISHMENT.
The
6
application for
a
7
calendar days before the date planned for opening a
8
ESTABLISHMENT
9
requirements established by the
REGULATORY
PERMIT
by the applicant.
11
8-302.12
12
A
13
to the
14
on a form provided by the
15
8-302.13
16
To qualify for a
17
(A)
PERSON
18
at least
FOOD
may accept an
AUTHORITY
that is less than the minimum 30
provided
10
PERMIT
the necessary fees
FOOD
and
other
REGULATORY AUTHORITY
are met
Form of Submission.
desiring to operate a
REGULATORY AUTHORITY
FOOD ESTABLISHMENT
shall submit
a written application for a
PERMIT
REGULATORY AUTHORITY.
Qualifications and Responsibilities of Applicants.
PERMIT,
an applicant shall:
Be an owner of the
FOOD ESTABLISHMENT
or an officer of
the legal ownership;
19
(B)
Comply with the requirements of this Code;
20
(C)
As specified under § 8-402.11, agree to allow access to
21
the
22
information; and
23
(D)
24
Pay
FOOD
the
ESTABLISHMENT
applicable
and
PERMIT
to
fees
provide
at
the
required
time
the
application is submitted.
25
8-302.14
26
The application shall include:
27
(A)
Contents of the Application.
The name, birth date, mailing address, telephone number,
28
and signature of the
29
the name, mailing address, and location of the
30
ESTABLISHMENT;
208
PERSON
applying for the
PERMIT
and
FOOD
1
(B)
Information specifying whether the
2
owned
3
partnership, or other legal entity;
4
5
(C)
an
association,
corporation,
individual,
A statement specifying whether the
FOOD ESTABLISHMENT:
(1)
and
6
7
by
04.05.11
is
FOOD ESTABLISHMENT
Is
mobile
or
stationary
temporary
or
permanent, and
(2)
Is an operation that includes one or more of the
8
following:
9
(a)
Prepares, offers for sale, or serves POTENTIALLY
10
HAZARDOUS FOOD (TIME/TEMPERATURE CONTROL FOR
11
SAFETY FOOD):
12
(i)
13
Only
to
order
upon
CONSUMER'S
request,
14
(ii)
In
advance in quantities based on
15
projected
16
discards
17
served at an
APPROVED
Using
as
18
(iii)
19
20
a
CONSUMER
FOOD
time
demand
and
that is not sold or
the
frequency, or
public
health
control as specified under § 3-501.19,
(b)
Prepares
POTENTIALLY
HAZARDOUS
FOOD
21
(TIME/TEMPERATURE
22
in advance using a
23
that involves two or more steps which may
24
include
25
(TIME/TEMPERATURE
26
ingredients; cooking; cooling; reheating; hot
27
or cold holding; freezing; or thawing,
28
(c)
Prepares
CONTROL FOR SAFETY FOOD)
combining
FOOD
FOOD
preparation method
POTENTIALLY
HAZARDOUS
CONTROL FOR SAFETY FOOD)
as
specified
under
29
Subparagraph (C)(2)(b) of this section for
30
delivery to and consumption at a location off
209
1
the PREMISES of the
2
it is prepared,
3
(d)
Prepares
FOOD
04.05.11
FOOD ESTABLISHMENT where
as
under
Subparagraph
4
(C)(2)(b) of this section for service to a
5
HIGHLY SUSCEPTIBLE POPULATION,
6
(e)
Prepares only
7
HAZARDOUS
8
SAFETY FOOD),
9
(f)
11
HAZARDOUS
12
SAFETY FOOD);
14
15
CONTROL
OF
or
FOOD
that is not
(TIME/TEMPERATURE
POTENTIALLY
CONTROL
FOR
The name, title, address, and telephone number of the
PERSON
(E)
POTENTIALLY
Does not prepare, but offers for sale only
prePACKAGED
(D)
that is not
(TIME/TEMPERATURE
10
13
FOOD
directly responsible for the
FOOD ESTABLISHMENT;
The name, title, address, and telephone number of the
16
PERSON
who functions as the immediate supervisor of the
17
PERSON
specified under ¶ (D) of this section such as the
18
zone, district, or regional supervisor;
19
(F)
20
The names, titles, and addresses of:
(1)
The
PERSONS
comprising the legal ownership as
21
specified under ¶ (B) of this section including the
22
owners and officers, and
23
(2)
24
25
26
on the type of legal ownership;
(G)
A statement signed by the applicant that:
(1)
27
28
The local resident agent if one is required based
Attests to the accuracy of the information provided
in the application, and
(2)
Affirms that the applicant will:
29
(a)
Comply with this Code, and
30
(b)
Allow the
210
REGULATORY AUTHORITY
access to
the establishment
2
8-402.11 and to the records specified under
3
§§ 3-203.12 and 5-205.13 and Subparagraph
4
8-201.14(D)(6); and
5
6
(H)
Issuance
as
Other information required by the
8-303.10
REGULATORY AUTHORITY.
New, Converted, or Remodeled Establishments.
7
For
that are required to submit plans as
8
specified under § 8-201.11 the
9
a
FOOD ESTABLISHMENTS
PERMIT
specified
04.05.11
under §
1
REGULATORY AUTHORITY
shall issue
to the applicant after:
10
(A)
A properly completed application is submitted;
11
(B)
The required fee is submitted;
12
(C)
The required plans, specifications, and information are
13
14
reviewed and
(D)
APPROVED;
and
A preoperational inspection as specified in § 8-203.10
15
shows that the establishment is built or remodeled in
16
accordance with the
17
and that the establishment is in compliance with this
18
Code.
19
8-303.20
plans and specifications
APPROVED
Existing Establishments, Permit Renewal, and
20
Change of Ownership.
21
The
22
FOOD ESTABLISHMENT
23
existing FOOD ESTABLISHMENT after a properly completed application is
24
submitted, reviewed, and
25
inspection shows that the establishment is in compliance with
26
this Code.
27
8-303.30
28
If
29
REGULATORY AUTHORITY
30
that includes:
REGULATORY AUTHORITY
an
may renew a
or may issue a
PERMIT
APPROVED,
PERMIT
for an existing
to a new owner of an
the fees are paid, and an
Denial of Application for Permit, Notice.
application
for
a
PERMIT
to
operate is denied, the
shall provide the applicant with a notice
211
1
(A)
2
04.05.11
The specific reasons and Code citations for the PERMIT
denial;
3
(B)
The actions, if any, that the applicant must take to
qualify for a
4
5
(C)
PERMIT;
and
Advisement of the applicant's right of appeal and the
6
process and time frames for appeal that are provided
7
in
8
Conditions of
8-304.10
9
Retention
(A)
LAW .
Responsibilities of the Regulatory Authority
At the time a
PERMIT is first issued, the REGULATORY AUTHORITY
10
shall inform the
11
the
12
requirements and the conditions of retention, as specified
13
under § 8-304.11, that are applicable to the
14
(B)
PERMIT
PERMIT HOLDER
HOLDER
is
about the Code so that
notified
of
the
compliance
PERMIT.
Failure to provide the information specified in ¶ (A) of this
15
section does not prevent the
16
taking authorized action or seeking remedies if the
17
HOLDER
18
warning, or directive of the
8-304.11
20
Upon acceptance of the
21
AUTHORITY,
22
(A)
24
the
Post the
PERMIT HOLDER
PERMIT
in order to retain the
in a location in the
REGULATORY
PERMIT
shall:
FOOD ESTABLISHMENT
CONSUMERS;
Comply with the provisions of this Code including the
conditions of a granted
26
§ 8-103.12, and
27
§ 8-201.12;
(C)
REGULATORY AUTHORITY.
issued by the
PERMIT
25
28
PERMIT
Responsibilities of the Permit Holder.
that is conspicuous to
(B)
from
fails to comply with this Code or an order,
19
23
REGULATORY AUTHORITY
If a
VARIANCE
APPROVED
FOOD ESTABLISHMENT
plans as specified under
is required under § 8-201.13 to
29
operate under a HACCP
30
specified under § 8-103.12;
212
as specified under
PLAN,
comply with the plan as
1
(D)
Immediately contact the
2
illness of a
3
specified under ¶ 2-201.11(B);
4
(E)
5
Immediately discontinue
CONDITIONAL EMPLOYEE
operations
and
notify
as
the
as specified under § 8-404.11;
(F)
Allow representatives of the
8
to
9
§ 8-402.11;
10
or
FOOD EMPLOYEE
REGULATORY AUTHORITY if an IMMINENT HEALTH HAZARD may exist
6
7
04.05.11
to report an
REGULATORY AUTHORITY
(G)
the
FOOD
REGULATORY AUTHORITY
as
ESTABLISHMENT
specified
access
under
Except as specified under ¶ (H) of this section, replace
11
existing facilities and
12
with facilities and
13
if:
14
(1)
The
EQUIPMENT
EQUIPMENT
specified in § 8-101.10
that comply with this Code
REGULATORY AUTHORITY
directs the replacement
15
because the facilities and
16
public health
17
comply with the criteria upon which the facilities
18
and
EQUIPMENT
The
REGULATORY AUTHORITY directs
19
(2)
HAZARD
the facilities and
21
of ownership, or
(3)
24
the replacement of
because of a change
EQUIPMENT
The facilities and
23
or nuisance or no longer
were accepted,
20
22
constitute a
EQUIPMENT
EQUIPMENT
are replaced in the
normal course of operation;
(H)
Upgrade or replace refrigeration
as specified
25
under
26
circumstances specified under Subparagraphs (G)(1) - (3)
27
of this section do not occur first, and 5 years pass after
28
the
29
30
(I)
Subparagraph
EQUIPMENT
REGULATORY AUTHORITY
Comply
with
directives
3-501.16(A)(2)(b),
if
the
adopts this Code;
of the
REGULATORY AUTHORITY
including time frames for corrective actions specified in
213
1
04.05.11
inspection reports, notices, orders, warnings, and other
2
directives issued by the
3
the
4
to community emergencies;
5
(J)
PERMIT HOLDER'S FOOD ESTABLISHMENT
AUTHORITY
(K)
according to
LAW ;
in regard to
or in response
Accept notices issued and served by the
6
7
REGULATORY AUTHORITY
REGULATORY
and
Be subject to the administrative, civil, injunctive, and
8
criminal remedies authorized in
9
with
this
Code
or
a
LAW
directive
including time
for failure to comply
of
the
REGULATORY
10
AUTHORITY,
frames for corrective actions
11
specified in inspection reports, notices, orders, warnings,
12
and other directives.
13
8-304.20
14
A
15
PERSON,
16
type of operation to
17
from the type of operation specified in the application as
18
specified under ¶ 8-302.14(C) and the change in operation is
19
not
Permits Not Transferable.
PERMIT
shall not be transferred from one
from one
FOOD ESTABLISHMENT
another if the
PERSON
to another, or from one
FOOD
operation changes
APPROVED.
20
21
22
8-4
INSPECTION AND CORRECTION OF VIOLATIONS
Subparts
23
8-401
Frequency
24
8-402
Access
25
8-403
Report of Findings
26
8-404
Imminent Health Hazard
27
8-405
Violation of Critical Item
28
8-406
Noncritical Violation
29
214
to another
1
2
04.05.11
Frequency
8-401.10
(A)
3
Except as specified in ¶¶ (B) and (C) of this section, the
REGULATORY AUTHORITY shall
4
5
Establishing Inspection Interval.
inspect a
FOOD ESTABLISHMENT at
least once every 3 months.
(B)
6
The
REGULATORY AUTHORITY
of
the inspection if: The
may decrease the qualification
FOOD
ESTABLISHMENT
is fully
7
operating under an APPROVED and validated HACCP
8
PLAN
9
8-103.12(A) and (B);
10
(2)
as
specified under
§ 8-201.14 and
The establishment's operation involves only coffee
11
service and other unpackaged or prePACKAGED
12
that is not
CONTROL FOR
14
BEVERAGES
15
popcorn, and pretzels.
(C)
The
FOOD
POTENTIALLY HAZARDOUS (TIME/TEMPERATURE
13
16
¶¶
SAFETY
and snack
REGULATORY AUTHORITY
FOOD)
such as carbonated
FOOD
such as chips, nuts,
shall periodically
inspect
17
throughout its PERMIT period a TEMPORARY FOOD ESTABLISHMENT
18
and
19
sells, or serves unPACKAGED
20
(TIME/TEMPERATURE CONTROL FOR SAFETY FOOD) and that:
21
(1)
TEMPORARY FOOD SERVICE ESTABLISHMENT
that prepares,
POTENTIALLY HAZARDOUS FOOD
Has improvised rather than permanent facilities or
22
EQUIPMENT
for accomplishing functions such as
23
handwashing,
24
FOOD
25
DRINKING WATER,
26
insect and rodent control; or
FOOD
preparation
temperature control,
and
protection,
WAREWASHING,
providing
waste retention and disposal, and
27
(2)
Has inexperienced
FOOD EMPLOYEES.
28
8-401.20
29
Within the parameters specified in § 8-401.10, the
30
AUTHORITY
Performance- and Risk-Based.
REGULATORY
shall prioritize, and conduct more frequent inspections
215
based upon its assessment of a
2
compliance with this Code and the establishment's potential as
3
a vector of foodborne illness by evaluating:
4
(A)
5
Past performance, for nonconformance with Code
HACCP
6
(B)
7
(C)
9
Past performance, for numerous or repeat violations of
PLAN
requirements that are noncritical;
Past performance, for complaints investigated and found
to be valid;
10
(D)
11
The
HAZARDS
associated with the particular
FOODS
that are
prepared, stored, or served;
12
(E)
13
The type
of
operation including
extent of
FOOD
(F)
The number of people served; and
15
(G)
Whether the population served is a
16
the
methods
and
storage, preparation, and service;
14
HIGHLY SUSCEPTIBLE
POPULATION.
17
8-402.10
18
An authorized representative of the
19
inspects
20
compliance with this
21
and ability to adequately perform the required duties.
22
or
requirements that are critical;
PLAN
Code or HACCP
8
FOOD ESTABLISHMENT'S
04.05.11
history of
1
Access
Competency of Inspectors.
a
or
FOOD ESTABLISHMENT
8-402.11
who
REGULATORY AUTHORITY
conducts plan review for
Code shall have the knowledge, skills,
Allowed at Reasonable Times after Due Notice.
23
After the
24
provides notice of the purpose of, and an intent to conduct, an
25
inspection,
26
AUTHORITY
27
compliance
28
establishment, allowing inspection, and providing information and
29
records specified in this Code and to which the
30
AUTHORITY
REGULATORY AUTHORITY
the
to
PERSON
is
IN CHARGE
determine
with
this
entitled
presents official credentials and
if
the
Code
according
216
shall allow the
REGULATORY
FOOD ESTABLISHMENT
by
to
is
in
allowing access to the
LAW ,
during
REGULATORY
the
FOOD
1
ESTABLISHMENT'S
2
8-402.20
04.05.11
hours of operation and other reasonable times.
Refusal, Notification of Right to Access, and Final
3
Request for Access.
4
If a
5
REGULATORY AUTHORITY
6
(A)
PERSON
denies access to the
Inform the
7
(1)
REGULATORY AUTHORITY,
shall:
PERSON
that:
The
PERMIT HOLDER
8
the
REGULATORY
9
§ 8-402.11 of this Code,
10
(2)
is required to allow access to
AUTHORITY
as
specified
under
Access is a condition of the acceptance and
11
retention of a
12
as specified under ¶ 8-304.11(F), and
13
the
(3)
FOOD ESTABLISHMENT PERMIT
If access is denied, the
14
to operate
FOOD ESTABLISHMENT PERMIT
may be suspended by the
REGULATORY AUTHORITY.
15
(B)
Make a final request for access.
16
8-402.30
17
If after the
18
notice as specified under § 8-402.11, explains the authority upon
19
which access is requested, and makes a final request for
20
access as specified in § 8-402.20, the
21
continues to
22
provide details of the denial of access on an inspection report
23
form.
24
8-402.40
25
If denied access to a
26
purpose
27
AUTHORITY
28
ESTABLISHMENT.
29
Report of
8-403.10
30
Findings
The
Refusal, Reporting.
REGULATORY AUTHORITY
REFUSE
presents credentials and provides
access, the
PERSON
IN CHARGE
REGULATORY AUTHORITY
shall
Refusal, Automatic Suspension of Permit.
FOOD ESTABLISHMENT
for an authorized
and after complying with § 8-402.20, the
shall immediately suspend
the
PERMIT
REGULATORY
of the
FOOD
Documenting Information and Observations.
REGULATORY AUTHORITY
217
shall document on an inspection report
1
form:
2
(A)
04.05.11
Administrative information about the
3
legal identity,
street
4
establishment
and
5
8-302.14(C), inspection date, and other information such
6
as type of water supply and
7
the
8
required; and
9
(B)
PERMIT,
and
and
FOOD ESTABLISHMENT'S
mailing
operation
personnel
as
addresses, type of
specified
SEWAGE
under
¶
disposal, status of
certificates
that
may
be
Specific factual observations of violative conditions or other
10
deviations from this Code that require correction by the
11
PERMIT HOLDER
12
(1)
including:
Failure of the
PERSON IN CHARGE
to demonstrate the
13
knowledge
of
foodborne
14
application
of
HACCP
15
requirements of this Code as specified under §
16
2-102.11,
17
(2)
illness
prevention,
principles,
and
the
Failure of FOOD EMPLOYEES, CONDITIONAL EMPLOYEES, and
18
the
19
condition as specified under ¶¶ 2-201.11(B) and (D),
PERSON IN CHARGE
20
(3)
Nonconformance with
21
(4)
Failure
to report a disease or medical
CRITICAL ITEMS
of the appropriate
demonstrate
23
perform
24
monitoring, verification,
and
25
practices required by the
REGULATORY AUTHORITY
26
specified under § 8-103.12,
(5)
in
Failure of the
knowledge
EMPLOYEES
22
27
their
FOOD
of this Code,
to
of, and ability to
accordance with, the procedural,
PERSON IN CHARGE
corrective
action
as
to provide records
28
required by the
29
conformance with a HACCP PLAN as specified under
30
Subparagraph 8-201.14(D)(6), and
218
REGULATORY AUTHORITY for determining
1
(6)
2
Nonconformance with
PLAN.
3
8-403.11
4
(a)
Grading of Food Establishment
Every
FOOD
ESTABLISHMENT
5
designated
6
stating the grade received
7
recent
8
REGULATORY AUTHORITY
9
placard.
10
(b)
11
12
04.05.11
of a HACCP
CRITICAL LIMITS
by the
REGULATORY
inspection
TEMPORARY
shall
of
at
the
display in a place
AUTHORITY,
a placard
the time of the most
establishment. Only the
may issue, move, or remove such
FOOD ESTABLISHMENT
shall not be subject to
grading.
(c)
13
Grades of
1)
FOOD ESTABLISHMENT
Grade A. A
shall be as follows:
having a demerit
FOOD ESTABLISHMENT
score of not more than ten (10).
14
15
2)
Grade B. A
having a demerit
FOOD ESTABLISHMENT
16
score of more than ten (10) but no more than
17
twenty (20).
18
3)
Grade C. A
FOOD ESTABLISHMENT
having a demerit
19
score of more than twenty (20) but no more than
20
forty
21
established above, whenever a second consecutive
22
violation of the same item of 2, 4, or 6 demerit
23
points
24
suspended,
or
25
ESTABLISHMENT
shall be downgraded to the next
26
lower grade.
27
(d)
(40).
Immediately
is
AUTHORITY
29
ESTABLISHMENT.
8-403.30
discovered,
in
the
the
grade criteria
PERMIT
lieu thereof,
following such inspection, the
28
30
Notwithstanding
may
the
be
FOOD
REGULATORY
shall post the appropriate grade at the
FOOD
Issuing Report and Obtaining Acknowledgment of
219
04.05.11
1
Receipt.
2
At the conclusion of the inspection and according to
3
REGULATORY AUTHORITY
4
inspection report and the notice to correct violations to the
5
PERMIT HOLDER
6
signed acknowledgment of receipt.
7
8-403.40
8
The
9
(A)
shall
LAW ,
the
provide a copy of the completed
or to the
PERSON IN CHARGE,
and request a
Refusal to Sign Acknowledgment.
REGULATORY AUTHORITY
Inform
a
shall:
PERSON
who
declines
to
sign
an
10
acknowledgment of receipt of inspectional findings as
11
specified in § 8-403.30 that:
12
(1)
13
An acknowledgment of receipt is not an agreement
with findings,
14
(2)
Refusal to sign an acknowledgment of receipt will
15
not affect the
16
the violations noted in the inspection report within
17
the
18
(3)
PERMIT HOLDER'S
obligation to correct
time frames specified, and
A refusal to sign an acknowledgment of receipt
19
is noted in the inspection report and conveyed to
20
the
21
FOOD ESTABLISHMENT;
22
(B)
23
REGULATORY AUTHORITY'S
historical record for the
and
Make a final request that the
PERSON IN CHARGE
sign an
acknowledgment receipt of inspectional findings.
24
8-403.50
25
Except as specified in § 8-202.10, the
26
treat the inspection report as a public document and shall
27
make it available for disclosure to a
28
as provided in
29
Imminent Health
8-404.11
30
Hazard
(A)
Public Information.
REGULATORY AUTHORITY shall
PERSON
who requests it
LAW .
Ceasing Operations and Reporting.
Except as specified in ¶ (B) of this section, a
220
PERMIT
04.05.11
shall immediately discontinue operations and notify
1
HOLDER
2
the
3
may exist because of
4
flood, extended interruption of electrical or water service,
5
SEWAGE
REGULATORY AUTHORITY
if an
IMMINENT HEALTH HAZARD
an emergency such as a fire,
backup, misuse of
POISONOUS OR TOXIC MATERIALS,
6
onset of an apparent foodborne illness outbreak, gross
7
insanitary occurrence or condition, or other circumstance
8
that may endanger public health.
9
B)
A
PERMIT HOLDER
need not discontinue operations in an
10
area of an establishment that is unaffected by the
11
IMMINENT HEALTH HAZARD.
12
8-404.12
13
If operations are discontinued as specified under § 8-404.11 or
14
otherwise according to
15
approval from the REGULATORY AUTHORITY before resuming operations.
16
Violation of
8-405.11
17
Critical
(A)
18
Item
Resumption of Operations.
LAW ,
shall obtain
Except as specified in ¶ (B) of this section, a
HOLDER
PERMIT
shall at the time of inspection correct a violation
of a
20
actions for a HACCP
21
compliance with its
(B)
PERMIT HOLDER
Timely Correction.
19
22
the
CRITICAL ITEM
of this Code and implement corrective
PLAN
provision that is not in
CRITICAL LIMIT
Considering the nature of the potential
HAZARD
involved
23
and the complexity of the corrective action needed, the
24
REGULATORY AUTHORITY
25
time frame, not to exceed 10 calendar days after the
26
inspection, for the
27
of a
28
8-405.20
29
(A)
30
CRITICAL ITEM
may agree to or specify a longer
PERMIT HOLDER
or HACCP
PLAN
to correct violations
deviations.
Verification and Documentation of Correction.
After observing at the time of inspection a correction of a
violation of a
CRITICAL ITEM
221
or deviation, the
REGULATORY
04.05.11
shall enter the violation and information about
1
AUTHORITY
2
the corrective action on the inspection report.
3
(B)
As
specified
under ¶ 8-405.11(B),
after
receiving
4
notification that the
5
violation of a
6
at
7
REGULATORY
8
violation, document the information on an inspection
9
report, and enter the report in the
10
the
PERMIT
CRITICAL ITEM
end
of
the
AUTHORITY
has corrected a
HOLDER
or HACCP
specified
shall
PLAN
period
verify
deviation, or
of
time,
correction
of
the
the
REGULATORY AUTHORITY'S
records.
11
Noncritical
8-406.11
12
Violation
(A)
Time Frame for Correction.
Except as specified in ¶ (B) of this section, the
PERMIT
13
HOLDER
14
time agreed to or specified by the
15
but no later than 30 calendar days after the inspection.
16
(B)
The
shall correct noncritical violations by a date and
REGULATORY AUTHORITY
may
REGULATORY AUTHORITY
approve a compliance
17
schedule that extends beyond the time limits specified
18
under ¶ (A)
19
compliance is submitted by the
20
health
21
extended schedule for compliance.
of
HAZARD
this
section
if a written schedule of
PERMIT HOLDER
and no
exists or will result from allowing an
22
23
8-5
PREVENTION OF FOODBORNE DISEASE TRANSMISSION BY
24
EMPLOYEES
25
Subpart
26
8-501
Investigation and Control
8-501.10
Obtaining Information: Personal History
27
28
Investigation
29
and Control
30
of
Illness, Medical Examination, and Specimen
Analysis.
222
04.05.11
shall act when it has reasonable
1
The
2
cause to believe that
3
EMPLOYEE
4
with a disease in a communicable form that is transmissible
5
through
6
cause a disease that is transmissible through
7
affected with a boil, an infected wound, or
8
infection, by:
9
(A)
REGULATORY AUTHORITY
FOOD;
11
disease
or making
12
appropriate; and
Requiring
CONDITIONAL
may be infected
infectious
Securing a confidential medical
or
or
EMPLOYEE
may be a carrier of
EMPLOYEE
(B)
FOOD
has possibly transmitted disease;
10
13
a
agents
FOOD;
appropriate
or is
acute respiratory
history of the
CONDITIONAL EMPLOYEE suspected of
other
that
FOOD
transmitting
investigations as
deemed
medical examinations, including
14
collection of specimens for laboratory analysis, of a
15
suspected
16
8-501.20
FOOD EMPLOYEE
or
CONDITIONAL EMPLOYEE.
Restriction or Exclusion of Food Employee, or
17
Summary Suspension of Permit.
18
Based on the findings of an investigation related to a
19
EMPLOYEE
20
infected or diseased, the
21
order to the suspected
22
PERMIT HOLDER
23
measures:
24
(A)
RESTRICTING the
25
(B)
EXCLUDING the
26
(C)
Closing the
27
28
29
30
a
8-501.30
or
CONDITIONAL EMPLOYEE
PERMIT
FOOD
who is suspected of being
REGULATORY AUTHORITY
may issue an
FOOD EMPLOYEE, CONDITIONAL EMPLOYEE
or
instituting one or more of the following control
FOOD EMPLOYEE
FOOD EMPLOYEE
or
FOOD ESTABLISHMENT
or
CONDITIONAL EMPLOYEE;
CONDITIONAL EMPLOYEE; or
by summarily suspending
to operate in accordance with
LAW .
Restriction or Exclusion Order: Warning or Hearing
Not Required, Information Required in Order.
Based on the findings of the investigation as specified in
223
04.05.11
1
§ 8-501.10 and to control disease transmission, the
2
AUTHORITY
3
suspected
4
warning, notice of a hearing, or a hearing if the order:
5
(A)
6
7
may issue an order of
FOOD EMPLOYEE
or the
States the reasons for the
(B)
9
reasons
10
RESTRICTION
or
to a
without prior
EXCLUSION
that is
FOOD EMPLOYEE
or
PERMIT
shall provide in order to demonstrate that the
for
the
RESTRICTION
or
are
EXCLUSION
eliminated;
(C)
States that the suspected
FOOD EMPLOYEE
12
HOLDER
13
timely request as provided in
(D)
or the
LAW ;
and
Provides the name and address of the
AUTHORITY
16
appeal hearing may be made.
8-501.40
PERMIT
may request an appeal hearing by submitting a
15
17
EXCLUSION
PERMIT HOLDER
States the evidence that the
HOLDER
14
or
ordered;
8
11
RESTRICTION
REGULATORY
representative to whom a
REGULATORY
request
for
an
Removal of Exclusions and Restrictions.
18
19
The
20
CONDITIONAL EMPLOYEE
21
LAW
REGULATORY AUTHORITY
from
shall release a
RESTRICTION
or
FOOD EMPLOYEE, OR
EXCLUSION
according to
and the conditions specified under § 2-201.13.
22
8-501.50
23
The
24
in order to determine its compliance with this Code.
Examining, Sampling, and Testing Food.
REGULATORY AUTHORITY
224
may examine, sample, and test
FOOD
1
Guam Annex
1
2
Public Health Reasons
3
CHAPTER 1
PURPOSE AND DEFINITIONS
4
CHAPTER 2
MANAGEMENT AND PERSONNEL
5
CHAPTER 3
FOOD
6
CHAPTER 4
EQUIPMENT, UTENSILS, AND LINENS
7
CHAPTER 5
WATER, PLUMBING, AND WASTE
8
CHAPTER 6
PHYSICAL FACILITIES
9
CHAPTER 7
POISONOUS OR TOXIC MATERIALS
10
CHAPTER 8
COMPLIANCE AND ENFORCEMENT
11
Chapter 1 Purpose and Definitions
12
13
Applicability and
1-201.10
Statement of Application and Listing
14
Terms Defined
15
(B)
16
The individual definitions in Chapter 1 are not numbered, consistent with current
17
conventions regarding the use of plain language in drafting rules, and with use in
18
national and international standards and some Federal regulations. This facilitates
19
making changes to the definitions as they become necessary in subsequent
20
editions of the Food Code. The intent of the definitions to be binding in terms of the
21
application and interpretation of the Code is clearly stated in Chapter 1.
22
Accredited Program.
23
Food protection manager certification occurs when individuals demonstrate through
24
a certification program that they have met specified food safety knowledge
25
standards.
of Terms.
Terms Defined
Guam Food Code Annex 1 – Public Health Reasons
1
1
Food protection certification program accreditation occurs when certification
2
organizations demonstrate through an accreditation program that they have met
3
specified program standards.
4
Accreditation is a conformity assessment process through which organizations that
5
certify individuals may voluntarily seek independent evaluation and listing by an
6
accrediting agency based upon the certifying organization meeting program
7
accreditation standards. Such accreditation standards typically relate to such
8
factors as the certifying organization's structure, mission, policies, procedures, and
9
the defensibility of its examination processes. These standards are intended to
10
affirm or enhance the quality and credibility of the certification process, minimize the
11
potential for conflicts of interest, ensure fairness to candidates for certification and
12
others, and thereby increase public health protection.
13
Program accreditation standards known to be relevant to food protection manager
14
certification programs include those contained in the Standards for Accreditation of
15
Food Protection Manager Certification Programs available from the Conference for
16
Food Protection, 1085 Denio Avenue, Gilroy, CA 95020-9206 and found at
17
http://www.foodprotect.org/pdf/standards.pdf.
18
Allowing food protection managers to demonstrate their required food safety
19
knowledge “through passing a test that is part of an accredited program” is
20
predicated on the fact that their credentials have been issued by certifying
21
organizations that have demonstrated conformance with rigorous and nationally
22
recognized program standards.
23
Food Establishment and a food processing plant located within the same
24
premises of a Food Establishment
25
Some food businesses perform operations that provide food directly to consumers
26
as a “Food Establishment,” and also supply food to other business entities as a
27
“Food Processing Plant.” Within such a business, those operations that provide
28
food directly to consumers only should be considered part of a “Food
29
Establishment” for the purposes of applying the Food Code while those operations
30
that supply food to other business entities may be subject to other rules and
Guam Food Code Annex 1 – Public Health Reasons
2
1
regulations that apply to “Food Processing Plants.” It is essential that the permit
2
holder and persons in charge be aware that regulatory requirements and the
3
appropriate operational practices for “Food Establishments” may differ from those
4
for “Food Processing Plants.”
5
Some facilities and functions may be subject to different regulatory requirements
6
depending on whether that facility or function is regulated as a “Food
7
Establishment” or as a “Food Processing Plant,” or both. Those facilities and
8
functions within a business that are shared by both the “Food Establishment” and
9
“Food Processing Plant” operations, e.g., refrigeration units, dressing room and
10
toilet facilities, food equipment, water and waste systems, pest control, might be
11
subject to similar regulatory requirements. The Food Code is intended to apply to
12
“food establishments.”
13
Egg.
14
The definition of egg includes avian species‟ shell eggs known to be commercially
15
marketed in the United States. Also included are the eggs of quail and ratites such
16
as ostrich.
17
Not included are baluts. Baluts are considered a delicacy among Philippine and
18
Vietnamese populations. They are derived from fertile eggs, typically duck eggs,
19
subjected to incubation temperatures for a period of time less than necessary for
20
the embryo to hatch resulting in a partially formed embryo within the shell. Under
21
the Egg Products Inspection Act (EPIA), an egg is typically considered adulterated
22
if it has been subjected to incubation. However, in 9 CFR 590.5, baluts are
23
specifically exempted from inspection as eggs under the EPIA.
24
In producing baluts, fertile duck eggs are incubated for approximately 18 days at a
25
temperature of 42.5°C (108.5°F) in incubators with a relatively high humidity.
26
(Complete development and hatching would take place in 28 days.) Under these
27
conditions, the potential for growth of transovarian Salmonella organisms such as
28
S. Enteritidis within the shell, and the potential for an increase in pathogenic
29
microflora on the shell itself, are increased. Where chicken eggs are used in
Guam Food Code Annex 1 – Public Health Reasons
3
1
preparing baluts, the incubation period may only be 14 days at an incubation
2
temperature of 37°C (99°F).
3
(time/temperature control for safety food) subject to time/temperature management
4
including proper cooking and hot and cold holding. Baluts are typically boiled and
5
packed in salt before sale or service. Also, not included in this definition are the
6
eggs of reptile species such as alligators and turtles. Alligator eggs are available
7
for sale in some parts of the southern United States. In restaurants, the menu item
8
“Alligator Eggs” is sometimes made of alligator egg, but other times is simply a
9
fanciful name for a menu item that may include seafood items such as shrimp, but
A balut is a potentially hazardous food
10
contains no alligator egg.
11
Sea turtle eggs have been consumed in Asian and Latin American Countries.
12
However, turtle eggs are not mentioned in the definitions section because sea
13
turtles (Loggerhead, East Pacific Green, Leatherback, Hawksbill, Kemp‟s Ridley,
14
and Olive Ridley) are protected by The Endangered Species Act of 1973 and
15
therefore may not be sold or consumed. This Act, with respect to turtle eggs, is
16
enforced by the United States Department of Interior, U.S. Fish and Wildlife
17
Service, Washington, D.C.
18
Potentially Hazardous Food (Time/Temperature Control for Safety Food)
19
Potentially hazardous food (PHF/TCS food) is defined in terms of whether or not it
20
requires time/temperature control for safety to limit pathogen growth or toxin
21
formation. The term does not include foods that do not support growth but may
22
contain a pathogenic microorganism or chemical or physical food safety hazard at a
23
level sufficient to cause foodborne illness or injury. The progressive growth of all
24
foodborne pathogens is considered whether slow or rapid.
25
The definition of PHF/TCS food takes into consideration pH, a w, pH and aw
26
interaction, heat treatment, and packaging for a relatively simple determination of
27
whether the food requires time/temperature control for safety. If the food is heat-
28
treated to eliminate vegetative cells, it needs to be addressed differently than a raw
29
product with no, or inadequate, heat treatment. In addition, if the food is packaged
30
after heat treatment to destroy vegetative cells and subsequently packaged to
Guam Food Code Annex 1 – Public Health Reasons
4
1
prevent re-contamination, higher ranges of pH and/or aw can be tolerated because
2
remaining spore-forming bacteria are the only microbial hazards of concern. While
3
foods will need to be cooled slightly to prevent condensation inside the package,
4
they must be protected from contamination in an area with limited access and
5
packaged before temperatures drop below 57°C (135°F). In some foods, it is
6
possible that neither the pH value nor the aw value is low enough by itself to control
7
or eliminate pathogen growth; however, the interaction of pH and aw may be able to
8
accomplish it. This is an example of a hurdle technology. Hurdle technology
9
involves several inhibitory factors being used together to control or eliminate
10
pathogen growth, when they would otherwise be ineffective if used alone.
11
In determining if time/temperature control is required, combination products present
12
their own challenge. A combination product is one in which there are two or more
13
distinct food components and an interface between the two components may have a
14
different property than either of the individual components. A determination must
15
be made about whether the food has distinct components such as pie with meringue
16
topping, focaccia bread, meat salads, or fettuccine alfredo with chicken or whether
17
it has a uniform consistency such as gravies, puddings, or sauces. In these
18
products, the pH at the interface is important in determining if the item is a
19
PHF/TCS food.
20
A well designed inoculation study or other published scientific research should be
21
used to determine whether a food can be held without time/temperature control
22
when:
23
process technologies other than heat are applied to destroy foodborne
24
pathogens (e.g., irradiation, high pressure processing, pulsed light,
25
ozonation);
26
combination products are prepared; or
27
other extrinsic factors (e.g., packaging/atmospheres) or intrinsic factors (e.g.,
28
redox potential, salt content, antimicrobials) are used to control or eliminate
29
pathogen growth.
Guam Food Code Annex 1 – Public Health Reasons
5
1
Before using Tables A and B in paragraph 1-201.10(B) of the definition for
2
“potentially hazardous food (time/temperature control for safety food)” in
3
determining whether a food requires time/temperature control for safety (TCS),
4
answers to the following questions should be considered:
5
Is the intent to hold the food without using time or temperature control?
6
o If the answer is No, no further action is required. The decision tree later
7
in this Annex is not needed to determine if the item is a PHF/TCS food.
8
Is the food raw, or is the food heat-treated?
9
Does the food already require time/temperature control for safety by
10
definition in paragraph 1-201.10(B)?
11
Does a product history with sound scientific rationale exist indicating a safe
12
history of use?
13
Is the food processed and packaged so that it no longer requires TCS such
14
as ultra high temperature (UHT) creamers or shelf-stable canned goods?
15
What is the pH and aw of the food in question using an independent
16
laboratory and Association of Official Analytical Chemists (AOAC) methods
17
of analysis?
18
A food designated as product assessment required (PA), in either table should be
19
considered PHF/TCS Food until further study proves otherwise. The PA means that
20
based on the food's pH and aw and whether it was raw or heat-treated or packaged,
21
it has to be considered PHF until inoculation studies or some other acceptable
22
evidence shows that the food is a PHF/TCS food or not. The Food Code requires a
23
variance request to the regulatory authority with the evidence that the food does not
24
require time/temperature control for safety.
25
The Food Code definition designates certain raw plant foods as PHF/TCS food
26
because they have been shown to support the growth of foodborne pathogens in
27
the absence of temperature control and to lack intrinsic factors that would inhibit
28
pathogen growth. Unless product assessment shows otherwise, these designations
29
are supported by Tables A and B. For example:
Guam Food Code Annex 1 – Public Health Reasons
6
1
For cut cantaloupe (pH 6.2-7.1, aw > 0.99, not heat-treated), fresh sprouts (pH >
2
6.5, aw > 0.99, not heat-treated), and cut tomatoes (pH 4.23 - 5.04, aw > 0.99, not
3
heat-treated), Table B indicates that they are considered PHF/TCS foods unless a
4
product assessment shows otherwise.
5
temperature control requirements prescribed in this code for PHF/TCS food will limit
6
the growth of pathogens that may be present in or on the food and may help
7
prevent foodborne illness.
8
If a facility adjusts the pH of a food using vinegar, lemon juice, or citric acid for
9
purposes other than flavor enhancement, a variance is required under ¶ 3-
10
502.11(C). A HACCP plan is required whether the food is a PHF/TCS food as in
11
subparagraph 3-502.11(C)(1) or not a PHF/TCS food, as in subparagraph 3-
12
502.11(C)(2). A standardized recipe validated by lab testing for pH and aw would
13
be an appropriate part of the variance request with annual (or other frequency as
14
specified by the regulatory authority) samples tested to verify compliance with the
15
conditions of the variance.
16
More information can be found in the Institute of Food Technologists (IFT) Report,
17
Evaluation and Definition of Potentially Hazardous Foods.
18
Instructions for using the following Decision Tree and Table A and Table B:
19
1.
Maintaining these products under the
Does the operator want to hold the food without using time or temperature
20
control?
21
a.
22
No – Continue holding the food at ≤5°C(41°F) or ≥57°C(135°F) for
safety and/or quality.
23
b.
Yes – Continue using the decision tree to identify which table to use
24
to determine whether time/temperature control for safety (TCS) is
25
required.
26
27
2.
Is the food heat-treated?
a.
No – The food is either raw, partially cooked (not cooked to the
28
temperature specified in section 3-401.11 of the Food Code) or
29
treated with some other method other than heat. Proceed to step #3.
Guam Food Code Annex 1 – Public Health Reasons
7
1
b.
Yes – If the food is heat-treated to the required temperature for that
2
food as specified under section 3-401.11 of the Food Code,
3
vegetative cells will be destroyed although spores will survive.
4
Proceed to step #4.
5
3.
6
Is the food treated using some other method?
a.
7
No –The food is raw or has only received a partial cook allowing
vegetative cells and spores to survive. Proceed to step #6.
8
b.
Yes – If a method other than heat is used to destroy pathogens such
9
as irradiation, high pressure processing, pulsed light, ultrasound,
10
inductive heating, or ozonation, the effectiveness of the process
11
needs to be validated by inoculation studies or other means. Proceed
12
to step #5.
13
4.
14
Is it packaged to prevent re-contamination?
a.
15
No – Re-contamination of the product can occur after heat treatment
because it is not packaged. Proceed to step #6.
16
b.
Yes – If the food is packaged immediately after heat treatment to
17
prevent re-contamination, higher ranges of pH and/or a w can be
18
tolerated because spore-forming bacteria are the only microbial
19
hazard. Proceed to step #7.
20
5.
21
Further product assessment or vendor documentation required.
a.
The vendor of this product may be able to supply documentation that
22
inoculation studies indicate the food can be safely held without
23
time/temperature control for safety.
24
b.
Food prepared or processed using new technologies may be held
25
without time/temperature control provided the effectiveness of the use
26
of such technologies is based on a validated inoculation study.
27
6.
Using the food‟s known pH and/or aw values, position the food in the
28
appropriate table.
29
a.
30
Choose the column under “pH values” that contains the pH value of
the food in question.
Guam Food Code Annex 1 – Public Health Reasons
8
1
b.
2
Choose the row under “aw values” that contains the aw value of the
food in question.
3
c.
Note where the row and column intersect to identify whether the food
4
is “non-PHF/non-TCS food” and therefore does not require
5
time/temperature control, or whether further product assessment (PA)
6
is required.
7
microorganisms, salt content, or processing methods may allow the
8
product to be held without time/temperature control but an inoculation
9
study is required.
10
7.
11
12
13
Other factors such as redox potential, competitive
Use Table A for foods that are heat-treated and packaged OR use Table B
for foods that are not heat-treated or heat-treated but not packaged.
8.
Determine if the item is non-PHF/non-TCS or needs further product
assessment (PA).
Guam Food Code Annex 1 – Public Health Reasons
9
1
2
3
#1 Does the operator want to
hold the food without using time
or temperature control?
4
5
6
NO
7
YES
8
9
No further action required.
#2 Is the food heat-treated?
10
11
NO
YES
12
13
14
#4 Is it packaged to
prevent re-contamination?
#3 Is the food treated using some
other method?
15
16
YES
NO
NO
YES
17
18
19
20
#6 Using the food‟s known pH
and/or aw values, position the food
in the appropriate table.
#5 Further PA or vendor
documentation required.
21
22
#7 Use Table A
#7 Use Table B
23
24
25
26
27
28
Non-PHF/Non-TCS
Food may be held
out of temperature or
time control and is
considered shelfstable.
Product
Assessment
Further PA or
vendor
documentation
required.
Non-PHF/Non-TCS
Food may be held
out of temperature or
time control and is
considered shelfstable.
29
Guam Food Code Annex 1 – Public Health Reasons
10
Product
Assessment
Further PA or
vendor
documentation
required.
1
2
3
4
5
6
7
8
9
10
11
12
Guam Food Code Annex 1 – Public Health Reasons
11
1-201.10(B) – Table A and Table B
1
2
3
Table A. Interaction of pH and aw for control of spores in food heat-treated to
4
destroy vegetative cells and subsequently packaged
5
aw values
PH
6
values
4.6 or less
> 4.6 - 5.6
non-PHF*/non-TCS
non-PHF/non-
> 5.6
7
8
≤0.92
9
FOOD**
TCS FOOD
non-PHF/non-TCS
non-PHF/non-
FOOD
TCS FOOD
non-PHF/non-TCS
PA
non-PHF/nonTCS FOOD
10
11
> 0.92 - .95
12
PA***
13
14
> 0.95
15
PA
FOOD
16
17
*
18
** TCS food means Time/Temperature Control for Safety food
19
*** PA means Product Assessment required
PHF means Potentially Hazardous Food
20
21
22
Table B. Interaction of pH and aw for control of vegetative cells and spores in
23
food not heat-treated or heat-treated but not packaged
24
aw values
25
PH
values
< 4.2
4.2 - 4.6
> 4.6 - 5.0
> 5.0
non-PHF*/
non-PHF/
non-PHF/
non-PHF/
28
non- TCS
non-TCS
non-TCS
non-TCS food
29
FOOD**
food
food
26
27
< 0.88
30
Guam Food Code Annex 1 – Public Health Reasons
12
1
0.88 – 0.90
non-PHF/ non-PHF/
non-PHF/
2
non-TCS
non-TCS
non-TCS
3
FOOD
food
food
non-PHF/
non-PHF/
6
non-TCS
non-TCS
7
FOOD
food
PA***
4
5
> 0.90 – 0.92
PA
PA
PA
PA
8
9
> 0.92
non-PHF/
10
non-TCS
11
FOOD
PA
12
13
*
14
** TCS food means Time/Temperature Control for Safety food
15
*** PA means Product Assessment required
PHF means Potentially Hazardous Food
16
Guam Food Code Annex 1 – Public Health Reasons
13
Chapter 2 Management and Personnel
1
2-101.11
Assignment.*
2
Responsibility
3
Designation of a person in charge during all hours of operations ensures the
4
continuous presence of someone who is responsible for monitoring and managing
5
all food establishment operations and who is authorized to take actions to ensure
6
that the Code's objectives are fulfilled. During the day-to-day operation of a food
7
establishment, a person who is immediately available and knowledgeable in both
8
operational and Code requirements is needed to respond to questions and
9
concerns and to resolve problems.
10
In cases where a food establishment has several departments on the premises
11
(e.g., a grocery store with deli, seafood, and produce departments) and the
12
regulatory authority has permitted those departments individually as separate food
13
establishments, it may be unnecessary from a food safety standpoint to staff each
14
department with a separate Person in Charge during periods when food is not being
15
prepared, packaged or served. While activities such as moving food products from
16
a refrigerated display case to the walk-in refrigerator, cleaning the floors, or doing
17
inventory when the department is not busy, do take place during these times, a
18
designated Person in Charge for multiple departments or the entire facility can
19
oversee these operations and be ready to take corrective actions if necessary.
20
Knowledge
21
The designated person in charge who is knowledgeable about foodborne disease
22
prevention, Hazard Analysis and Critical Control Point (HACCP) principles, and
23
Code requirements is prepared to recognize conditions that may contribute to
24
foodborne illness or that otherwise fail to comply with Code requirements, and to
25
take appropriate preventive and corrective actions.
26
There are many ways in which the person in charge can demonstrate competency.
27
Many aspects of the food operation itself will reflect the competency of that person.
28
A dialogue with the person in charge during the inspection process will also reveal
29
whether or not that person is enabled by a clear understanding of the Code and its
2-102.11
Demonstration.*
Guam Food Code Annex 1 – Public Health Reasons
14
1
public health principles to follow sound food safety practices and to produce foods
2
that are safe, wholesome, unadulterated, and accurately represented.
3
The Food Code does not require reporting of uninfected cuts or reporting of
4
covered, protected infected cuts/lesions/boils since no bare hand contact with
5
ready-to-eat (RTE) food is a Code requirement.
2-102.20
6
Food Protection Manager Certification.
7
Many food protection manager certification programs have shared a desire to have
8
the food manager certificates they issue universally recognized and accepted by
9
others – especially by the increasing number of regulatory authorities that require
10
food manager certification.
11
Needed has been a mechanism for regulatory authorities to use in determining
12
which certificates should be considered credible based on which certificate issuing
13
programs meet sound organizational and certification procedures and use
14
defensible processes in their test development and administration.
15
After a multi-year effort involving a diversity of stakeholder groups, the Conference
16
for Food Protection (CFP) completed work on its Standards for Accreditation of
17
Food
18
http://www.foodprotect.org/pdf/standards.pdf. In 2002 the Conference entered into
19
a cooperative agreement with the American National Standards Institute (ANSI) to
20
provide independent third-party evaluation and accreditation of certification bodies
21
determined to be in conformance with these Conference standards.
22
published its first listing of accredited certifiers in 2003.
23
The Acting Commissioner of the Food and Drug Administration, in his address
24
before the 2004 biennial meeting of the Conference for Food Protection,
25
commended this Conference achievement and encouraged universal acceptance
26
based on the CFP/ANSI accreditation program.
27
Distributed at this meeting was the following letter addressed to the Conference
28
Chair and signed by the Director of FDA‟s Center for Food Safety and Applied
29
Nutrition. The letter puts forth the Agency‟s basis for its support of universal
30
acceptance of food protection manager certifications.
Protection
Manager
Certification
Programs
Guam Food Code Annex 1 – Public Health Reasons
15
found
at
ANSI
1
“The 2004 biennial meeting of the Conference for Food Protection is a
2
fitting occasion for FDA‟s Center for Food Safety and Applied Nutrition to
3
commend the Conference for its significant achievements in support of State
4
and local food safety programs.
5
The FDA in a Memorandum of Understanding recognizes the Conference for
6
Food Protection as a voluntary national organization qualified to develop
7
standards to promote food protection.
8
contribute to improvements in the model FDA Food Code and help
9
jurisdictions justify, adopt and implement its provisions.
Conference recommendations
10
Conference mechanisms involving active participation by representatives of
11
diverse stakeholder groups produce consensus standards of the highest
12
quality.
13
Accreditation of Food Protection Manager Certification Programs, and
14
its announcement of the new on-line listing of accredited certifiers of industry
15
food protection managers.
16
Conference standards identify the essential components necessary for a
17
credible certification program.
18
requirements such as detailed criteria for exam development and
19
administration, and responsibilities of the certification organization to
20
candidates and the public.
21
FDA applauds the Conference for this significant achievement, and
22
encourages agencies at all levels of government to accept certificates issued
23
by listed certifiers as meeting their jurisdictions‟ food safety knowledge and
24
certification requirements.
25
(ANSI) has independently evaluated these certification programs under an
26
agreement with the Conference for Food Protection. Governments and
27
industry widely recognize and respect ANSI as an accrediting organization.
28
ANSI has found certifiers it lists as accredited (http://www.ansi.org/) under
29
“conformity assessment” – “personnel certification accreditation” to conform
An excellent example is the Conference‟s Standards for
Many years in their development, these
Components cover a wide range of
The American National Standards Institute
Guam Food Code Annex 1 – Public Health Reasons
16
1
to the Conference‟s Standards for Accreditation of Food Protection
2
Manager Certification Programs.*
3
The Food Code states the person in charge of a food establishment is
4
accountable for developing, carrying out, and enforcing procedures aimed at
5
preventing food-borne illness. Section 2-102.11 states that one means by
6
which a person in charge may demonstrate required knowledge of food
7
safety is through certification as a food protection manager by passing an
8
examination that is part of an accredited program.
9
FDA encourages food regulatory authorities and others evaluating
10
credentials for food protection managers to recognize the Conference for
11
Food Protection/ANSI means of accrediting certification programs. This
12
procedure provides a means for universal acceptance of individuals who
13
successfully demonstrate knowledge of food safety. The procedure provides
14
officials assurance that food safety certification is based on valid, reliable,
15
and legally defensible criteria. In addition, universal acceptance eliminates
16
the inconvenience and unnecessary expense of repeating training and
17
testing when managers work across jurisdictional boundaries.
18
FDA, along with State, local, tribal, and other Federal agencies and the food
19
industry, share the responsibility for ensuring that our food supply is safe. It
20
is anticipated that this new Conference for Food Protection/ANSI program
21
will lead to enhanced consumer protection, improve the overall level of food
22
safety, and be an important component of a seamless national food safety
23
system.”
2-103.11
Person in Charge.
24
Duties
25
A primary responsibility of the person in charge is to ensure compliance with Code
26
requirements. Any individual present in areas of a food establishment where food
27
and food-contact items are exposed presents a potential contamination risk. By
*ANSI‟s “Directory of Accredited Personnel Certification Programs utilizing Conference for Food Protection
(CFP) Standards” may be viewed on-line by going to http://www.ansi.org. Select “Accreditation Services” in the menu
on the left. Then select “ANSI Accredited Personnel Certification Bodies and Applicants” in the new left-hand menu
under the heading “Personnel Certification Accreditation.”
Guam Food Code Annex 1 – Public Health Reasons
17
1
controlling who is allowed in those areas and when visits are scheduled and by
2
assuring that all authorized persons in the establishment, such as delivery,
3
maintenance and service personnel, and pest control operators, comply with the
4
Code requirements, the person in charge establishes an important barrier to food
5
contamination.
6
Tours of food preparation areas serve educational and promotional purposes;
7
however, the timing of such visits is critical to food safety. Tours may disrupt
8
standard or routine operational procedures, and the disruption could lead to unsafe
9
food. By scheduling tours during nonpeak hours the opportunities for contamination
10
are reduced.
11
Paragraph (L) “EMPLOYEES are properly trained in FOOD safety as it relates to their
12
assigned duties” allows industry to develop and implement operational-specific
13
training programs for food employees. It is not intended to require that all food
14
employees pass a test that is part of an accredited program.
15
2-2
16
Overall goals
17
The purpose of this section of the Food Code is to reduce the likelihood that certain
18
viral and bacterial agents will be transmitted from infected food workers into food.
19
The agents of concern are known to be readily transmissible via food that has been
20
contaminated by ill food workers, and so for that reason, are the primary focus of
21
the Employee Health section of the Food Code. However, there are different levels
22
of risk associated with different levels of clinical illness. The structure of the
23
restrictions and exclusions has, therefore, been designed in a tiered fashion
24
depending on the clinical situation to offer the maximum protection to public health
25
with the minimal disruption to employees and employers.
26
Four levels of illness or potential illness have been identified with the first level
27
being the highest potential risk to public health and the fourth level being the
28
lowest. The first level relates to employees who have specific symptoms (e.g.,
29
vomiting, diarrhea, jaundice) while in the workplace. These symptoms are known to
Employee Health
Guam Food Code Annex 1 – Public Health Reasons
18
1
be associated commonly with the agents most likely to be transmitted from infected
2
food workers through contamination of food.
3
employees who have been diagnosed with typhoid fever or an infection with
4
hepatitis A virus (within 14 days of symptoms).
5
employees who have been diagnosed with the specific agents that are of concern,
6
but who are not exhibiting symptoms of disease because their symptoms have
7
resolved. The third level relates to employees who are diagnosed with the specific
8
agents, but never develop any gastrointestinal symptoms. The fourth level relates
9
to those individuals who are clinically well but who may have been exposed to a
The first level also relates to
The second level relates to
10
listed pathogen and are within the normal incubation period of disease.
11
The most significant degree of restriction and exclusion applies to the first level of
12
food employee illness. Infected food employees in the first level are likely to be
13
excreting high levels of their infectious pathogen, increasing the chance of
14
transmission to food products, and thus on to those consuming the food. The first
15
level includes food employees who are:
16
Experiencing active symptoms of diarrhea or vomiting – with no
17
diagnosis,
18
Experiencing jaundice within the last 7 days-- with no diagnosis,
19
Diagnosed with typhoid fever,
20
Diagnosed with hepatitis A within 7 days of jaundice or 14 days of
21
any symptoms, or
22
Experiencing active symptoms of diarrhea or vomiting, and diagnosed
23
with Norovirus, E. coli O157:H7 or other Enterohemorrhagic
24
Escherichia coli (EHEC) or Shiga toxin-producing Escherichia coli
25
(STEC), or Shigella spp. infection.
26
Diagnosis with typhoid fever or hepatitis A virus is included in level 1 because
27
employees diagnosed with these pathogens are likely to be shedding high levels of
28
the pathogen in their stool without exhibiting gastrointestinal symptoms. Peak
29
levels of hepatitis A viral shedding in the feces typically occurs before symptoms
30
appear. Diarrhea and vomiting are reliable indicators of infection with Norovirus, E.
Guam Food Code Annex 1 – Public Health Reasons
19
1
coli O157:H7 or other EHEC, and Shigella spp., but are not typical symptoms of
2
typhoid fever or hepatitis A. For example, employees diagnosed with typhoid fever
3
are more likely to experience constipation, rather than diarrhea. Jaundice is also
4
not always reliable as an indicator of a hepatitis A infection because employees
5
can be infected with hepatitis A virus without experiencing jaundice (anicteric
6
employees).
7
Maximum protection to public health requires excluding food employees
8
suffering from typhoid fever, hepatitis A virus, or specific gastrointestinal symptoms
9
associated with diseases identified as likely to be transmitted through contamination
10
of food (See section 2-201.12, Tables 2-201.12 #1a and #1b in this Annex). This
11
situation describes the highest level of risk in transmitting pathogens to food, or
12
what we would find in the first level.
13
Food employees who have been diagnosed with one of the agents of concern, but
14
are not symptomatic because their symptoms have resolved, are still likely to be
15
carrying the infected agent in their intestinal tract. This makes such employees less
16
likely to spread the agent into food than others who are actually symptomatic, but
17
employees diagnosed with one of the agents of concern still pose an elevated
18
threat to public health. For this reason, there are a series of exclusions (if the
19
employees work in facilities serving highly susceptible populations (HSP)) and
20
restrictions (for non-HSP facilities) depending on the agent involved (See section 2-
21
201.12, Table #2). This situation describes the second level of risk in transmitting
22
pathogens to food.
23
Diagnosed, asymptomatic food employees who never develop symptoms are
24
typically identified during a foodborne illness outbreak investigation through
25
microbiological testing.
26
microbiologically tested, they will remain undetected and could therefore extend the
27
duration of a foodborne illness outbreak through continued contamination of food.
28
The Food Code provides restriction or exclusion guidelines for employees that are
29
identified through microbiological testing with an infection from a listed foodborne
30
pathogen, but are otherwise asymptomatic and clinically well (See section 2-201.12,
If infected and asymptomatic employees are not
Guam Food Code Annex 1 – Public Health Reasons
20
1
Table #3). The exclusion or restriction guidelines are applied until the identified
2
food employees no longer present a risk for foodborne pathogen transmission. This
3
situation describes the third level of risk in transmitting pathogens to food.
4
Some food employees or conditional employees may report a possible exposure to
5
an agent. For example, a food employee may have attended a function at which the
6
food employee ate food that was associated with an outbreak of shigellosis, but the
7
employee remains well. Such individuals fall into the category of having had a
8
potential exposure and present a lower risk to public health than someone who is
9
either symptomatic or who has a definitive diagnosis. They present a level of risk to
10
public health that is greater than if they had not had the exposure. The approach
11
taken in the Food Code to food employees who have had a potential exposure is
12
based on the incubation times (time between exposure and the onset of symptoms)
13
of the various agents. The times chosen for restriction are the upper end of the
14
average incubation periods for the specific agents. The reasoning is that this will
15
restrict food employees only up to the time when it is unlikely they will develop
16
symptoms. As a further protection to public health, it is recommended that such
17
exposed food employees pay particular attention to personal hygiene and report the
18
onset of any symptoms (See section 2-201.12, Table #4). This situation describes
19
the fourth level of risk in transmitting pathogens to food.
20
This structured approach has linked the degree of exclusion and restriction to the
21
degree of risk that an infected food worker will transmit an agent of concern into
22
food. The approach strikes a balance between protecting public health and the
23
needs of the food employee and employer.
Guam Food Code Annex 1 – Public Health Reasons
21
1
The Food Code provisions related to employee health are aimed at removing highly
2
infectious food employees from the work place.
3
recognition of the characteristics of the five important pathogens, and of the risk of
4
disease transmission associated with symptomatic and asymptomatic shedders.
5
The provisions also account for the increased risk associated with serving food to
6
HSP‟s and the need to provide extra protection to those populations.
7
The Employee Health section was developed and revised with assistance and input
8
from the Centers for Disease Control and Prevention (CDC) and the U.S. Equal
9
Employment Opportunity Commission (EEOC).
They were developed with
The exclusion and restriction
10
criteria are based on communicable disease information, as required by the
11
Americans with Disabilities Act of 1990, in the “The List of Infectious and
12
Communicable Diseases Which are Transmitted through the Food Supply“
13
published in the Federal Register on October 4, 2004, (Volume 69, Number 191) by
14
the CDC, and from the Control of Communicable Diseases Manual, 18th Ed., David
15
L. Heymann, MD, Editor, by the American Public Health Association, Washington
16
D.C., 2004.
17
18
2-201
Infected Food Employees and Conditional Employees
Practical Applications of Using Subpart 2-201
19
The information provided in Subpart 2-201 is designed to assist food establishment
20
managers and regulatory officials in removing infected food employees when they
21
are at greatest risk of transmitting foodborne pathogens to food.
22
applications of the information in Subpart 2-201 by a food establishment manager
23
may involve using Subpart 2-201 as a basis for obtaining information on the health
24
status of food employees and can also be used as a basis in developing and
25
implementing an effective Employee Health Policy. Regulatory officials can benefit
26
by using the information provided below as a basis for determining compliance with
27
Subpart 2-201 during a facility food safety inspection.
28
The development and effective implementation of an employee health policy based
29
on the provisions in Subpart 2-201 may help to prevent foodborne illness
30
associated with contamination of food by ill or infected food employees. The person
Guam Food Code Annex 1 – Public Health Reasons
22
Practical
1
in charge and food employees should be familiar with and able to provide the
2
following information through direct dialogue or other means when interviewed by
3
facility managers or regulatory officials. Compliance must be based, however, on
4
first hand observations or information and cannot be based solely on responses
5
from the person in charge to questions regarding hypothetical situations or
6
knowledge of
7
employee health policy, the following information should be considered and
8
addressed:
9
1.
the Food Code.
Also, when designing and implementing an
Does the establishment have an Employee Health Policy? If so, are
10
the food employees aware of the employee health policy, and is it
11
available in written format and readily available for food employees?
12
(Note: A written Employee Health Policy is not a Food Code
13
requirement unless the facility is operating under a pre-approved
14
alternative procedure specified under ¶ 3-301.11(D)).
15
2.
Does the establishment require conditional employees and food
16
employees to report certain illnesses, conditions, symptoms, and
17
exposures?
18
3.
Are the reporting requirements explained to all employees?
19
4.
What are the reporting requirements for conditional employees, food
20
21
employees, and the food establishment manager?
5.
Are conditional employees asked if they are experiencing certain
22
symptoms or illnesses upon offer of employment? If so, which
23
symptoms or illnesses?
24
6.
If a food employee reports a diagnosis with one of the 5 listed
25
pathogens in the Food Code, what questions are asked of the food
26
employee? (The first question every food manager should ask a food
27
employee who reports diagnosis with a listed pathogen is if the
28
employee is currently having any symptoms.)
29
30
7.
Who does the establishment notify when a food employee reports a
diagnosis with one of the listed pathogens?
Guam Food Code Annex 1 – Public Health Reasons
23
1
8.
2
3
employee from the food establishment?
9.
What history of exposure is a conditional employee or food employee
required to report?
4
5
What gastrointestinal symptoms would require exclusion of a food
10.
6
If a food employee reports a gastrointestinal symptom, what criteria
are used to allow the employee to return to work?
7
8
Responsibilities
2-201.11
Responsibility of the Person in Charge,
9
and Reporting
10
Symptoms and
11
Diagnosis
12
Proper management of a food establishment operation begins with employing
13
healthy people and instituting a system of identifying employees who present a risk
14
of transmitting foodborne pathogens to food or to other employees. The person in
15
charge is responsible for ensuring all food employees and conditional employees
16
are knowledgeable and understand their responsibility to report listed symptoms,
17
diagnosis with an illness from a listed pathogen, or exposure to a listed pathogen to
18
the person in charge. The person in charge is also responsible for reporting to the
19
regulatory official if a food employee reports a diagnosis with a listed pathogen.
20
This reporting requirement is an important component of any food safety program.
21
A food employee who suffers from any of the illnesses or medical symptoms or has
22
a history of exposure to a listed pathogen in this Code may transmit disease
23
through the food being prepared. The person in charge must first be aware that a
24
food employee or conditional employee is suffering from a disease or symptom
25
listed in the Code before steps can be taken to reduce the chance of foodborne
26
illness.
27
The person in charge may observe some of the symptoms that must be reported.
28
However, food employees and conditional employees share a responsibility for
29
preventing foodborne illness and are obligated to inform the person in charge if they
30
are suffering from any of the listed symptoms, have a history of exposure to one of
Food Employees and Conditional Employees.*
Guam Food Code Annex 1 – Public Health Reasons
24
1
the listed pathogens, or have been diagnosed with an illness caused by a listed
2
pathogen. Food employees must comply with restrictions or exclusions imposed
3
upon them.
4
A conditional employee is a potential food employee to whom a job offer has been
5
made, conditional on responses to subsequent medical questions or examinations.
6
A conditional employee becomes a food employee as soon as the employee begins
7
working, even if only on a restricted basis. When a conditional employee reports a
8
listed diagnosis or symptom, the person in charge is responsible for ensuring that
9
the conditional employee is prohibited from becoming a food employee until the
10
criteria for reinstatement of an exclusion are met (as specified under section
11
2-201.13 of the Food Code). When a symptomatic or diagnosed conditional
12
employee has met the same criteria for reinstatement that apply to an excluded
13
symptomatic or diagnosed food employee (as specified under section 2-201.13 of
14
the Food Code), the conditional employee may then begin working as a food
15
employee.
16
Reporting Symptoms:
17
In order to protect the health of consumers and employees, information concerning
18
the health status of conditional employees and food employees must be disclosed
19
to the person in charge. The symptoms listed in the Code cover the common
20
symptoms experienced by persons suffering from the pathogens identified by CDC
21
as transmissible through food by infected food employees. A food employee
22
suffering from any of the symptoms listed presents an increased risk of transmitting
23
foodborne illness.
24
The symptoms of vomiting, diarrhea, or jaundice serve as an indication that an
25
individual may be infected with a fecal-oral route pathogen, and is likely to be
26
excreting high levels of the infectious agent. When a food employee is shedding
27
extremely high numbers of a pathogen through the stool or vomitus, there is greater
28
chance of transmitting the pathogen to food products.
29
Sore throat with fever serves as an indication that the individual may be infected
30
with Streptococcus pyogenes. Streptococcus pyogenes causes a common infection
Guam Food Code Annex 1 – Public Health Reasons
25
1
otherwise known as “streptococcal sore throat” or “strep throat.” Streptococcal sore
2
throat can spread from contaminated hands to food, which has been the source of
3
explosive streptococcal sore throat outbreaks. Previous foodborne episodes with
4
streptococcus sore throat have occurred in contaminated milk and egg products.
5
Food products can be contaminated by infected food workers hands or from nasal
6
discharges. Untreated individuals in uncomplicated cases can be communicable for
7
10-21 days, and untreated individuals with purulent discharges may be
8
communicable for weeks or months.
9
Lesions containing pus that may occur on a food employee‟s hands, as opposed to
10
such wounds on other parts of the body, represent a direct threat for introducing
11
Staphylococcus aureus into food. Consequently, a double barrier is required to
12
cover hand and wrist lesions. Pustular lesions on the arms are less of a concern
13
when usual food preparation practices are employed and, therefore, a single barrier
14
is allowed. However, if the food preparation practices entail contact of the exposed
15
portion of the arm with food, a barrier equivalent to that required for the hands and
16
wrists would be necessitated. Lesions on other parts of the body need to be
17
covered; but an impermeable bandage is not considered necessary for food safety
18
purposes. Food employees should be aware that hands and fingers that contact
19
pustular lesions on other parts of the body or with the mucous membrane of the
20
nose also pose a direct threat for introducing Staphylococcus aureus into food.
21
If a food employee has an infected cut and bandages it and puts on a glove, the
22
employee does not have to report the infected cut to the person in charge.
23
However, if the employee does not bandage it, reporting is required.
24
Title I of the Americans with Disabilities Act of 1990 (ADA)
25
Title I of the Americans with Disabilities Act of 1990 (ADA) prohibits medical
26
examinations and inquiries as to the existence, nature, or severity of a disability
27
before extending a conditional offer of employment. In order for the permit holder
28
and the person in charge to be in compliance with this particular aspect of the Code
29
and the ADA, a conditional job offer must be made before making inquiries about
30
the applicant‟s health status.
Guam Food Code Annex 1 – Public Health Reasons
26
1
The ADA also requires that employers provide reasonable accommodation to
2
qualified applicants and employees with disabilities. A reasonable accommodation
3
is a change in the application process, in the way a job is done, or to other parts of
4
the job that enables a person with a disability to have equal employment
5
opportunities. ADA disabilities are serious, long-term conditions. Most people with
6
diseases resulting from the pathogens listed in the Food Code do not have ADA
7
disabilities because these diseases are usually short-term in duration. In addition,
8
the gastrointestinal symptoms listed in the Food Code usually are not long-term and
9
severe enough, in themselves, to be ADA disabilities. Of course, these symptoms
10
may be linked to other conditions that may be serious enough to be ADA
11
disabilities, like Crohn‟s disease or cancer.
12
A food employer may exclude any employee under the Food Code upon initially
13
learning that the employee has Salmonella Typhi, or has a gastrointestinal symptom
14
listed in the Food Code. The excluded employee may then ask for an ADA
15
reasonable accommodation instead of the exclusion. In response, the employer‟s
16
first step should be to ask the employee to establish that the employee is disabled
17
by the disease or symptom (or that the symptom is caused by another ADA
18
disability). If the employee successfully proves that the employee has an ADA
19
disability, then the employer may continue to exclude the employee under the Food
20
Code if:
21
there is no reasonable accommodation at work that would eliminate
22
the risk of transmitting the disease while also allowing the employee
23
to work in a food handling position, or
24
all reasonable accommodations would pose an undue hardship on
25
the employer‟s business; and
26
there is no vacant position not involving food handling for which the
27
employee is qualified and to which the employee can be reassigned.
28
Example 1:
A food employee working in the café of a department store informs the
29
employer that the employee has been diagnosed with a disease caused by
30
Salmonella Typhi. The employer immediately excludes the employee under the
Guam Food Code Annex 1 – Public Health Reasons
27
1
requirements of the Food Code. The employee then establishes that the disease is
2
an ADA disability because it is severe and long-term and the employee requests
3
reasonable accommodation instead of an exclusion. The employer determines that
4
no reasonable accommodation would eliminate the risk of transmitting Salmonella
5
Typhi through food and refuses to remove the exclusion. However, there is a
6
vacant clerical position in another part of the store for which the employee is
7
qualified. Unless the employer can establish that reassigning the employee to this
8
position would be an undue hardship, the employer‟s failure to make the
9
reassignment instead of continuing the exclusion would be a violation of the ADA.1
10
Example 2:
A food employee has diarrhea and is excluded. The employee
11
establishes that the diarrhea is caused by Crohn‟s disease. This employee also
12
establishes a serious longstanding history of Crohn‟s disease and is an individual
13
with an ADA disability. Crohn‟s disease is not a communicable disease and cannot
14
be transmitted through food. No reasonable accommodation is needed to eliminate
15
the risk of transmitting the disease through the food supply, so the Food Code
16
exclusion should be removed. Of course, the Food Code‟s provisions on personal
17
cleanliness for hands and arms apply as usual, requiring employees to clean hands
18
and exposed portions of arms after using the toilet room and in other specified
19
circumstances (Subpart 2-301).
20
Somewhat different rules apply to conditional employees. If a conditional employee
21
reports a disease or symptom listed in the Food Code and shows that the disease
22
or symptom makes the conditional employee an individual with an ADA disability,
23
the employer may withdraw the job offer only if:
24
The job involves food handling; and
25
The employer determines that either there is no reasonable
26
accommodation that would eliminate the risk of transmitting the
27
disease through food, or any such accommodation would be an
28
undue hardship to the business.
1
Whether or not the employee in question is an individual with an ADA disability, in those jurisdictions where the Code is
adopted, Food Code exclusions or restrictions must be removed when requirements for removal under § 2-201.13 of the
Code are met.
Guam Food Code Annex 1 – Public Health Reasons
28
1
There is no need to offer the conditional employee a vacant position
2
not involving food handling as a reasonable accommodation.
3
It should be noted that the information provided here about the ADA is intended to
4
alert employers to the existence of ADA and related CFR requirements. For a
5
comprehensive understanding of the ADA and its implications, consult the
6
references listed in Annex 2 that relate to this section of the Code or contact the
7
U.S. Equal Employment Opportunity Commission. See the Equal Employment
8
Opportunity Commission‟s How to Comply with the Americans with Disabilities Act:
9
A Guide for Restaurants and Other Food Service Employers, found at
10
http://www.eeoc.gov/facts/restaurant_guide.html
or
11
http://www.eeoc.gov/facts/restaurant_guide_summary.html for detailed information
12
about the interaction between the FDA Food Code and the ADA.
13
The information required from applicants and food employees is designed to
14
identify employees who may be suffering from a disease that can be transmitted
15
through food. It is the responsibility of the permit holder to convey to applicants and
16
employees the importance of notifying the person in charge of changes in their
17
health status. Once notified, the person in charge can take action to prevent the
18
likelihood of the transmission of foodborne illness.
19
conditional offer of employment is extended, and food employees are required to
20
report their specific history of exposure, medical symptoms, and previous illnesses.
21
The symptoms listed may be indicative of a disease that is transmitted through the
22
food supply by infected food employees.
23
As required by the ADA, the CDC published in the Federal Register on October 4,
24
2004, (Volume 69, Number 191) a list of infectious and communicable diseases that
25
are transmitted through food. The CDC updates the list annually.
26
See “List of Infectious and Communicable Diseases which are Transmitted
27
through the Food Supply“ at
28
http://a257.g.akamaitech.net/7/257/2422/06jun20041800/edocket.access.gpo.gov/2004/p
29
df/04-22260.pdf). The list is divided into two parts: pathogens often transmitted
30
and pathogens occasionally transmitted by infected persons who handle food.
Applicants, to whom a
Guam Food Code Annex 1 – Public Health Reasons
29
1
The following Lists summarize the CDC list by comparing the common symptoms
2
of each pathogen. Symptoms may include diarrhea, fever, vomiting, jaundice,
3
and sore throat with fever. The CDC has no evidence that the HIV virus is
4
transmissible via food. Therefore, a food employee positive for the HIV virus is
5
not of concern unless suffering secondary illness listed below. The following
6
Lists include all enterohemorrhagic or Shiga toxin-producing E. coli likely to
7
occur in foods in the United States.
8
LIST I.
Pathogens Often Transmitted by Food Contaminated by Infected
Persons Who Handle Food, and Modes of Transmission of Such
9
Pathogens.
10
11
12
D
F
V
J
S
13
14
1. Noroviruses
D
F
V
15
2. Hepatitis A virus
-
F
-
J
-
16
3. Salmonella Typhi
-
F
-
-
-
17
4. Shigella species
D
F
V
-
-
18
5. Staphylococcus aureus
D
-
V
-
-
19
6.. Streptococcus pyogenes
-
F
-
-
S
20
21
LIST II.
Pathogens Occasionally Transmitted by Food Contaminated by
22
Infected Persons Who Handle Food, But Usually Transmitted by
23
Contamination at the Source or in Food Processing or by Non-
24
foodborne Routes.
25
26
D
F
V
J
S
27
1. Campylobacter jejuni
D
F
V
-
-
28
2. Cryptosporidium parvum
D
-
-
-
-
29
3. Entamoeba histolytica
D
F
-
-
-
30
4. Enterohemorrhagic Escherichia coli
D
-
-
-
-
Guam Food Code Annex 1 – Public Health Reasons
30
1
5. Enterotoxigenic Escherichia coli D
-
V
-
-
2
6. Giardia lamblia
D
-
-
-
-
3
7. Non-typhoidal Salmonella
D
F
V
-
-
4
8. Taenia solium
-
-
-
-
-
5
9. Vibrio cholerae 01
D
-
V
-
-
6
10. Yersinia enterocolitica
D
F
V
-
-
7
8
9
KEY: D = Diarrhea
F = Fever
V = Vomiting
S = Sore throat with fever
J = Jaundice
10
The 5 Listed Pathogens:
11
The CDC has designated the 5 organisms listed in the Food Code as having high
12
infectivity via contamination of food by infected food employees. This designation is
13
based on the number of confirmed cases reported that involved food employees
14
infected with one of these organisms and/or the severity of the medical
15
consequences to those who become ill.
16
The following is taken from information provided in the 18th Edition of Control of
17
Communicable Diseases Manual, the CDC website, and the FDA Bad Bug Book,
18
and is provided as background information on pathogen virulence, infectivity, and
19
common symptoms exhibited with infection of each of the 5 listed pathogens.
20
NOROVIRUS
21
Noroviruses (genus Norovirus, family Caliciviridae) are a group of small (27-40nm),
22
round structured, single-stranded RNA, nonenveloped viruses that cause acute
23
gastroenteritis in humans. Norovirus has also been commonly known as “Norwalk-
24
like virus,” “Small Round-structured Virus,” and “Winter Vomiting Disease.”
25
The CDC estimates that Norovirus is the leading cause of foodborne illness in the
26
United States. Transmission of Norovirus has been shown to occur most commonly
27
through the fecal oral route, with contaminated food identified as a common vehicle
28
of transmission. Exclusion of food employees exhibiting or reporting diarrhea
29
symptoms is an essential intervention in controlling the transmission of Norovirus
Guam Food Code Annex 1 – Public Health Reasons
31
1
from infected food employees‟ hands to RTE food items. Norovirus also has a high
2
secondary attack rate (> 50%) via person-to-person contact.
3
Norovirus has also been reported to cause infection by airborne transmission when
4
individuals are in close physical proximity to an infected individual vomiting in the
5
facility. Therefore, an infected individual vomiting in a food facility increases the
6
risk of infecting employees and consumers. Foodborne illness outbreaks have
7
occurred from consumers vomiting in the dining room, or employees vomiting on the
8
premises. Removing food employees exhibiting or reporting vomiting symptoms
9
from the food facility protects consumers and fellow workers from infection with
10
Norovirus.
11
Incubation Period: Generally between 24 and 48 hours (median in outbreaks 33
12
to 36 hours), but cases can occur within 12 hours of exposure.
13
Symptoms and Complications: Acute-onset explosive (or projectile) vomiting,
14
watery non-bloody diarrhea with abdominal cramps, nausea, and occasionally, a
15
low grade fever. Symptoms usually last 24 to 60 hours. Vomiting is more common
16
in children. Recovery is usually complete and there is no evidence of any serious
17
long-term sequelae. Among the young and the elderly, dehydration is a common
18
complication. There is no long-term immunity to Norovirus and individuals may be
19
repeatedly infected throughout their lifetimes. There is no specific therapy for viral
20
gastroenteritis. Symptomatic therapy consists of replacement of fluid loss by the
21
administration of liquids orally, and in rare instances, through parenteral
22
intravenous fluid therapy. Earlier feeding studies conducted on Norovirus have
23
found that as many as 30% of individuals infected with Norovirus are asymptomatic.
24
Infectivity: Noroviruses are highly contagious, and it is thought that an inoculum of
25
as few as 10 viral particles may be sufficient to infect an individual. Although pre-
26
symptomatic shedding may occur, shedding usually begins with onset of symptoms
27
and may continue for 2 weeks after recovery. However, the degree of infectivity of
28
prolonged shedding has not been determined. Norovirus is shed at high levels in
29
the stool: 105 – 107/g or more.
30
SALMONELLA TYPHI
Guam Food Code Annex 1 – Public Health Reasons
32
1
Salmonella enterica subspecies enterica serovar Typhi (commonly S.Typhi) causes
2
a systemic bacterial disease, with humans as the only host. This disease is
3
relatively rare in the United States, with fewer than 500 sporadic cases occurring
4
annually in the U.S. Worldwide, the annual estimated incidence of Typhoid fever is
5
about 17 million cases with approximately 600,000 deaths. Currently, most cases of
6
S. Typhi in industrialized nations are imported into the country from developing
7
countries. Antibiotic-resistant strains have become prevalent in several areas of the
8
world.
9
Incubation period: Depends on inoculum size and on host factors: from 3 days to
10
over 60 days, with a usual range of 8 – 14 days.
11
Symptoms:
12
anorexia, relative bradycardia, splenomegaly, and nonproductive cough in the early
13
stage of the illness, rose spots on the trunk in 25% of white skinned patients and
14
constipation more often than diarrhea in adults. The illness varies from mild illness
15
with low-grade fever to severe clinical disease with abdominal discomfort and
16
multiple complications.
17
Infectivity: The minimal infectious dose is estimated to be less than 1000 bacterial
18
cells. An individual infected with S. Typhi is infectious as long as the bacilli appear
19
in the excreta, usually from the first week throughout the convalescence; variable
20
thereafter. About 10% of untreated typhoid fever patients will discharge bacilli for 3
21
months after onset of symptoms, and 2%-5% become permanent carriers; fewer
22
persons affected with paratyphoid organisms may become permanent gallbladder
23
carriers.
24
ENTEROHEMORRHAGIC OR SHIGA TOXIN-PRODUCING ESCHERICHIA COLI
25
E. coli O157:H7 is the most commonly identified strain of Enterohemorrhagic
26
Escherichia coli (EHEC) or Shiga toxin-producing Escherichia coli (STEC) as a
27
cause of foodborne illness in the United States. E. coli O157:H7 is a zoonotic
28
disease derived from cattle and other ruminants. However, E. coli O157:H7 also
29
readily transmits from person-to-person, so contaminated raw ingredients and ill
30
food employees both can be sources of foodborne disease. Other EHEC or STEC
Insidious onset of sustained fever, marked headache, malaise,
Guam Food Code Annex 1 – Public Health Reasons
33
1
serotypes have been identified as a source of foodborne illness in the United
2
States, however not as frequently as E. coli O157:H7. The other serogroups most
3
commonly implicated as a cause of foodborne illness in the United States are 026,
4
0111, 0103, 045, and 0121.
5
The Food Code definition of STEC covers all E. coli identified in clinical
6
laboratories that produce Shiga toxins. Nearly 200 O:H combinations of E. coli
7
have been shown to produce Shiga toxins. The Food Code definition includes all
8
STEC, including those that have not been specifically implicated in human disease
9
such as hemorrhagic colitis (i.e., bloody diarrhea) or hemolytic uremic syndrome
10
(HUS). A subset of STEC that has the capacity to both produce Shiga toxin and
11
cause “attaching and effacing” lesions in the intestine is classified as
12
“enterohemorrhagic” (EHEC). EHEC E. coli cause hemorrhagic colitis, meaning
13
bleeding enterically or bleeding from the intestine. Infections with EHEC may be
14
asymptomatic but are classically associated with bloody diarrhea (hemorrhagic
15
colitis) and hemolytic uremic syndrome (HUS) or thrombotic thrombocytopenic
16
purpura (TTP). Virtually all human isolates of E. coli O157:H7 serotypes are
17
EHEC.
18
Incubation period: From 2-10 days, with a median of 3-4 days.
19
Symptoms: The illness is characterized by severe cramping (abdominal pain) and
20
diarrhea with a range from mild and nonbloody to stools that are virtually all blood.
21
Occasionally vomiting occurs. Some individuals exhibit watery diarrhea only. Lack
22
of fever in most patients can help to differentiate this infection from other enteric
23
pathogens. About 8% of individuals with E. coli O157:H7 diarrhea progress to
24
HUS. This rate varies for other serotypes of Enterohemorrhagic E. coli.
25
Infectivity: The infectious dose is for example E. coli O157:H7 can be as low as
26
10 bacterial cells. Children under 5 years old are most frequently diagnosed with
27
infection and are at greatest risk of developing HUS. The elderly also experience a
28
greater risk of complications. The duration of excretion of Enterohemorrhagic E.
29
coli in the stool is typically 1 week or less in adults, but can be up to 3 weeks in
30
one-third of infected children.
Guam Food Code Annex 1 – Public Health Reasons
34
1
SHIGELLA SPP.
2
Causes an acute bacterial disease, known as shigellosis, and primarily occurs in
3
humans, but also occurs in other primates such as monkeys and chimpanzees. An
4
estimated 300,000 cases of shigellosis occur annually in the U.S. Shigella spp.
5
consist of 4 species or serogroups, including S. flexneri, S. boydii, S. sonnei, and
6
S. dysenteriae; which all differ in geographical distribution and pathogenicity.
7
Shigella spp. are highly infectious and highly virulent.
8
overcrowding conditions, where personal hygiene is poor, including in institutions,
9
such as prisons, mental hospitals, day care centers, and refugee camps, and also
10
among men who have sex with men. Water and RTE foods contaminated by feces,
11
frequently from food workers‟ hands, are common causes of disease transmission.
12
Multidrug-resistant Shigella (including S. dysenteriae 1) have appeared worldwide.
13
Concern over increasing antimicrobial resistance has led to reduced use of
14
antimicrobial therapy in treating shigellosis.
15
Incubation period: Usually 1 – 3 days, but ranges from 12 to 96 hours, and up to
16
1 week for S. dysenteriae 1.
17
Symptoms and Complications: Abdominal pain, diarrhea, fever, nausea, and
18
sometimes vomiting, tenesmus, toxaemia, and cramps. The stools typically contain
19
blood, pus, or mucus resulting from mucosal ulcerations. The illness is usually self-
20
limited, with an average duration of 4-7 days. Infections are also associated with
21
rectal bleeding, drastic dehydration, and convulsions in young children. The fatality
22
rate for Shigella dysenteriae 1 may be as high as 20% among hospitalized cases.
23
Other complications can also occur, such as Reiter‟s disease, reactive arthritis,
24
intestinal perforation, and hemolytic uremic syndrome.
25
Infectivity: The infectious dose for humans is low, with as few as 10 bacterial cells
26
depending on age and condition of the host. Infectivity occurs during acute
27
infection and until the infectious agent is no longer present in feces, usually within 4
28
weeks after illness. Asymptomatic carriers may transmit infection; rarely, the carrier
29
state may persist for months or longer.
30
HEPATITIS A VIRUS
Guam Food Code Annex 1 – Public Health Reasons
35
Outbreaks occur in
1
Hepatitis A virus (HAV) is a 27-nanometer picornavirus (positive strand RNA, non-
2
enveloped virus). The hepatitis A virus has been classified as a member of the
3
family Picornaviridae. The exact pathogenesis of HAV infection is not understood,
4
but the virus appears to invade from the intestinal tract and is subsequently
5
transported to the liver. The hepatocytes are the site of viral replication and the
6
virus is thought to be shed via the bile.
7
HAV is most commonly spread by the fecal-oral route through person-to-person
8
contact. Risk factors for reported cases of hepatitis A include personal or sexual
9
contact with another case, illegal drug use, homosexual male sex contact, and
10
travel to an endemic country. Common source outbreaks also can occur through
11
ingestion of water or food that has fecal contamination. However, the source of
12
infection is not identified for approximately 50% of reported cases.
13
HAV infection is endemic in developing countries, and less common in
14
industrialized countries with good environmental sanitation and hygienic practices.
15
In the developing world, nearly all HAV infections occur in childhood and are
16
asymptomatic or cause a mild illness.
17
infection with jaundice) is rarely seen in the developing world. More than 90% of
18
adults born in many developing countries are seropositive.
19
Children play an important role in the transmission of HAV and serve as a source of
20
infection for others, because most children have asymptomatic infections or mild,
21
unrecognized HAV infections. In the United States, the disease is most common
22
among school-aged children and young adults. After correction for under-reporting
23
and undiagnosed infections, an estimated 61,000 HAV infections (includes cases of
24
hepatitis A as well as asymptomatic infections) occurred in 2003.
25
HAV Immunization: Immune globulin can be used to provide passive pre-exposure
26
immunoprophylaxis against hepatitis A. Protection is immediately conferred to an
27
exposed individual following administration of IG, and immunity is provided for 3-5
28
months following inoculation. IG is effective in preventing HAV infection when given
29
as post-exposure immunoprophylaxis, if given within 14 days of exposure. When a
30
food service worker with hepatitis A is identified, IG is often given to co-workers.
As a result, hepatitis A (symptomatic
Guam Food Code Annex 1 – Public Health Reasons
36
1
Active immunoprophylaxis using hepatitis A vaccine (a formalin-inactivated,
2
attenuated strain of HAV) has been shown to provid immunity in > 95% of those
3
immunized, with minimal adverse reactions. Hepatitis A vaccination of food workers
4
has been advocated, but has not been shown to be cost-effective and generally is
5
not recommended in the United States, although it may be appropriate in some
6
communities.
7
Incubation period: Average 28 – 30 days (range 15 – 50 days).
8
Symptoms and Complications: Illness usually begins with symptoms such as
9
nausea/vomiting, diarrhea, abdominal pain, fever, headache, and/or fatigue.
10
Jaundice, dark urine or light colored stools might be present at onset, or follow
11
illness symptoms within a few days. HAV infection of older children and adults is
12
more likely to cause clinical illness with jaundice (i.e., hepatitis A); onset of illness is
13
usually
14
jaundiced. Jaundice generally occurs 5-7 days after the onset of gastrointestinal
15
symptoms. For asymptomatic infections, evidence of hepatitis may be detectable
16
only through laboratory tests of liver infections such as alanine aminotransferase
17
(ALT) tests. The disease varies in severity from a mild illness to a fulminant
18
hepatitis, ranging from 1-2 weeks to several months in duration. In up to 10-15% of
19
the reported cases, prolonged, relapsing hepatitis for up to 6 months occurs. The
20
degree of severity often increases with age; however, most cases result in complete
21
recovery, without sequelae or recurrence. The reported case fatality rate is 0.1% -
22
0.3% and can reach 1.8% for adults over 50 years old.
23
Diagnosis: Diagnosis of HAV infection requires specific serological testing for IgM
24
anti-HAV. IgM anti-HAV becomes undetectectable within 6 months of illness onset
25
for most persons; however, some persons can remain IgM anti-HAV positive for
26
years after acute infection. Total anti-HAV (the only other licensed serologic test)
27
can be detected during acute infection but remains positive after recovery and for
28
the remainder of the person‟s life.
29
Infectivity: Evidence indicates maximum infectivity during the latter half of the
30
incubation period, continuing for a few days after onset of jaundice. Most cases are
abrupt.
In young adults, 76-97% have symptoms and 40-70% are
Guam Food Code Annex 1 – Public Health Reasons
37
1
probably noninfectious after the first week of jaundice. Chronic shedding of HAV in
2
feces has not been reported. HAV is shed at peak levels in the feces, one to two
3
weeks before onset of symptoms, and shedding diminishes rapidly after liver
4
dysfunction or symptoms appear. Liver dysfunction or symptoms occur at the same
5
time circulating antibodies to HAV first appear. Immunity after infection probably
6
lasts for life; immunity after vaccination is estimated to last for at least 20 years.
7
Reporting History of Exposure:
8
The reporting requirements for history of exposure are designed to identify
9
employees who may be incubating an infection due to Norovirus, Shigella spp.,
10
E. coli O157:H7 or other EHEC/STEC, typhoid fever, or HAV.
11
Which employees who report exposure are restricted?
12
Employees who work in a food establishment serving a highly
13
susceptible population (HSP) facility.
14
What constitutes exposure?
15
Consuming a food that caused illness in another consumer due to
16
infection with Norovirus, Shigella spp., E. coli O157:H7 or other
17
EHEC/STEC, typhoid fever, or HAV.
18
Attending an event or working in a setting where there is a known
19
disease outbreak.
20
Close contact with a household member who is ill and is diagnosed
21
with a listed pathogen.
22
Why are other guidelines provided, in addition to restriction for employees serving
23
an HSP who report exposure to hepatitis A virus?
24
Employees who have had a hepatitis A illness in the past are most
25
likely protected from infection by life-time immunity to hepatitis A
26
infection.
27
Immunity developed through immunization or IgG inoculation
28
prevents hepatitis A infection in exposed employees.
29
Our standard definition of HSP doesn‟t apply very well to HAV.
30
Children under 6 years old who become infected with HAV are
Guam Food Code Annex 1 – Public Health Reasons
38
1
generally asymptomatic, and while a higher proportion of susceptible
2
elderly
3
institutionalized elderly are protected from HAV by prior infection.
4
who
become
infected
have
serious
illness,
most
What is the period of restriction?
5
The period of restriction begins with the most recent time of
6
foodborne or household member exposure and lasts for the usual
7
incubation period of the pathogen as defined in the Control of
8
Communicable Diseases Manual. This is the time that the employee
9
is most likely to begin shedding the pathogen.
10
o
For Norovirus, 48 hours after the most recent exposure
11
o
For Shigella spp., 3 days after the most recent exposure
12
o
For E. coli O157:H7 or other EHEC/STEC, 3 days after the
13
most recent exposure
14
o
15
For typhoid fever (S. Typhi), 14 days after the most recent
exposure
16
o
For HAV, 30 days after the most recent exposure
17
What is the period of restriction when exposed to a diagnosed, ill household
18
member?
19
While the household member is symptomatic with an infection due to
20
Norovirus, Shigella spp., E coli O157:H7 or other EHEC/STEC,
21
typhoid fever (S. Typhi) or HAV;
22
Plus during the usual incubation period of the pathogen of concern:
23
o
For Norovirus, symptomatic period plus 48 hours
24
o
For Shigella spp., symptomatic period plus 3 days
25
o
For E. coli O157:H7 or other EHEC/STEC, symptomatic period
26
plus 3 days
27
o
For typhoid fever (S. Typhi), symptomatic period plus 14 days
28
o
For HAV, onset of jaundice plus 30 days
29
What is the appropriate response to a report of exposure to other food employees?
30
Employees who report a history of exposure but who do not work in a HSP
Guam Food Code Annex 1 – Public Health Reasons
39
1
facility should be reminded of the requirements for reporting illness,
2
avoidance of bare hand contact with RTE foods, and proper hand washing
3
and personal hygiene.
2-201.12
4
Exclusions and Restrictions.2
5
Refer to public health reasons for § 2-201.11 for actions to take with conditional
6
employees.
7
It is necessary to exclude food employees symptomatic with diarrhea, vomiting, or
8
jaundice, or suffering from a disease likely to be transmitted through contamination
9
of food, because of the increased risk that the food being prepared will be
10
contaminated such as with a pathogenic microorganism. However, if the food
11
employee is suffering from vomiting or diarrhea symptoms, and the condition is from
12
a non-infectious condition, Crohn‟s disease or an illness during early stages of a
13
pregnancy, the risk of transmitting a pathogenic microorganism is minimal. In this
14
case, the food employee may remain working in a full capacity if they can
15
substantiate that the symptom is from a noninfectious condition.
16
employee can substantiate this through providing to the person in charge medical
17
documentation or other documentation proving that the symptom is from a
18
noninfectious condition.
19
Because of the high infectivity (ability to invade and multiply) and/or virulence
20
(ability to produce severe disease), of typhoid fever (Salmonella Typhi) and
21
hepatitis A virus, a food employee diagnosed with an active case of illness caused
22
by either of these two pathogens, whether asymptomatic or symptomatic, must be
23
excluded from food establishments. The exclusion is based on the high infectivity,
24
and/or the severe medical consequences to individuals infected with these
25
organisms. A food employee diagnosed with an active case of illness caused by
26
Norovirus, Shigella spp., or E. coli O157:H7 or other EHEC/STEC, is excluded if
2
The food
In order to comply with Title I of the Americans with Disabilities Act, an exclusion must also be removed if the employee
is entitled to a reasonable accommodation that would eliminate the risk of transmitting the disease. Reasonable
accommodation may include reassignment to another position in which the individual would not work around food. The
steps an employer must take when an excluded employee requests reasonable accommodation are briefly described in
Annex 3, § 2-201.11. However, it is not possible to explain all relevant aspects of the ADA within this Annex. When
faced with an apparent conflict between ADA and the Food Code‟s exclusion and restriction requirements, employers
should contact the U.S. Equal Employment Opportunity Commission.
Guam Food Code Annex 1 – Public Health Reasons
40
1
exhibiting symptoms of vomiting and diarrhea, and then allowed to work as the level
2
of risk of pathogen transmission decreases (See section 2-201.12, Tables #1b, #2
3
and #3).
4
The degree of risk for a food employee or conditional employee who is diagnosed
5
with an infection but asymptomatic with regard to symptoms, to transmit a foodborne
6
pathogen decreases with the resolution of symptoms. This risk decreases even
7
further for those employees that are diagnosed with a listed pathogen, but never
8
developed symptoms. The decrease in risk is taken under consideration when
9
excluding and restricting diagnosed food employees and results in a slight
10
difference in the way food employees diagnosed with Norovirus, but asymptomatic
11
with respect to gastrointestinal symptoms are handled (See section 2-201.12, Table
12
#2).
Guam Food Code Annex 1 – Public Health Reasons
41
1
2-201.11 / 2-201.12 Decision Tree 1. When to Exclude or Restrict a Food
2
Employee Who Reports a Symptom and When to Exclude a Food Employee
3
Who Reports a Diagnosis with Symptoms Under the Food Code
4
5
Is the Food Employee reporting listed symptoms?
6
7
Yes
8
9
10
11
12
Symptoms of
V, J, D
Symptoms of infected
wound or cut
Symptoms of
ST with F
V, J, D
13
14
15
16
Exclude per
Table 1a.
HSP
Gen. Pop.
(Non-HSP)
17
18
Exclude per
Table 1a.
19
20
21
Restrict per
Table 1a.
22
23
24
25
If reporting a diagnosis with hepatitis A virus, or typhoid fever
26
27
28
29
30
Exclude per
Table 1b.
Guam Food Code Annex 1 – Public Health Reasons
42
Restrict per
Table 1a.
1
2
3
4
If reporting a diagnosis with Shigellosis, Norovirus, or EHEC/STEC
and symptoms of V or D
5
6
7
8
9
Exclude per
Table 1b.
10
11
12
13
14
Key:
15
16
Listed Symptoms for Reporting: (V) Vomiting; (J) Jaundice; (D) Diarrhea; (ST with F) Sore Throat
with Fever; (HSP) Highly Susceptible Population; (Gen. Pop.) General Population
Guam Food Code Annex 1 – Public Health Reasons
43
1
2-201.11 / 2-201.12 Decision Tree 2. When to Exclude or Restrict a Food Employee Who
2
is Asymptomatic and Reports a Listed Diagnosis and When to Restrict a Food
3
Employee Who Reports a Listed Exposure Under the Food Code
4
Is the Food Employee reporting listed
symptoms?
5
6
7
8
No
9
10
11
12
Is the food employee reporting
diagnosis with infection due to . . .
13
14
Norovirus?
15
16
17
18
Shigella spp.
or EHEC?
S. Typhi or
Hepatitis A
virus?
No
19
20
21
22
23
24
25
Yes
Yes
Exclude
per
Table 2
or 3.
No
No
HSP
Exclude per
Table 2 or 3.
Yes
Gen. Pop.
(Non-HSP)
HSP
Restrict per
Table 2 or 3.
Exclude per
Table 2 or 3.
Gen. Pop.
(Non- HSP)
Restrict per
Table 2 or 3.
26
27
28
29
30
Guam Food Code Annex 1 – Public Health Reasons
44
1
Is the food employee reporting exposure to Norovirus, E. coli O157:H7 or
other EHEC, HAV, Shigella, or Typhoid fever (S. Typhi)?
2
3
4
5
Yes
No
6
7
Gen. Pop.
(Non-HSP)
HSP
No Action Necessary
8
9
10
Educate on symptoms; reinforce requirement to report listed
symptoms; ensure compliance with good hygienic practices,
handwashing, and no bare hand contact with ready-to-eat food.
Restrict per
Table 4.
11
12
13
14
15
16
17
Key:
(HSP) Highly Susceptible Population; (Gen. Pop.) General Population
2-201.12 Table 1a: Summary of Requirements for Symptomatic Food Employees
18
19
Food employees and conditional employees shall report symptoms
20
immediately to the person in charge
21
22
23
24
The person in charge shall prohibit a conditional employee that reports a listed symptom from becoming a food
employee until meeting the criteria listed in section 2-201.13 of the Food Code, for reinstatement of a
symptomatic food employee.
25
26
EXCLUSION/ OR RESTRICTION
Symptom
27
Facilities
28
Serving a HSP
29
30
31
32
33
Vomiting
Removing symptomatic food
RA Approval
employees from exclusion or
Needed to
restriction
Facilities not
EXCLUDE
serving a HSP
EXCLUDE
2-201.12(A)(1)
Return to
Work?
When the excluded food employee has
2-201.12(A)(1) been asymptomatic for at least 24 hours
or provides medical documentation
-201.13(A)(1).
Exceptions: If diagnosed with
Guam Food Code Annex 1 – Public Health Reasons
45
No if not
diagnosed
1
2
3
4
Norovirus, Shigella spp., E. coli
O157:H7 or other EHEC, HAV, or
typhoid fever (S. Typhi) (see Tables 1b
& 2).
5
6
7
8
9
10
11
Diarrhea
12
13
14
15
16
17
18
Jaundice
19
20
Sore Throat
EXCLUDE
with Fever
2-201.12(G)(1) 2-201.12(G)(2) medical documentation 201.13(G) (1)-(3).
21
22
23
24
Infected
RESTRICT
RESTRICT
When the infected wound or boil is
wound or
2-201.12(H)
2-201.12(H)
properly covered 2-201.13(H)(1)-(3).
EXCLUDE
EXCLUDE
2-201.12(A)(1)
When the excluded food employee has
2-201.12(A)(1) been asymptomatic for at least 24 hours
No if not
diagnosed
or provides medical documentation
2-201.13(A).
Exceptions: If Diagnosed with Norovirus,
E. coli O157:H7 or other EHEC, HAV, or
S. Typhi (see Tables 1b & 2).
EXCLUDE
EXCLUDE
When approval is obtained from the RA
2-201.12(B)(1)
2-201.12(B)(1) 2-201.13 (B), and:
if the onset
if the onset
occurred within
occurred within
jaundiced for more than 7
the last 7 days
the last 7 days
calendar days 2-201.13(B)(1), or
Yes
• Food employee has been
• Provides medical documentation
2-201.13(B)(3).
RESTRICT
When food employee provides written
pustular
boil
25
26
27
Key for Tables 1, 2, 3, and 4:
28
RA = Regulatory Authority
29
EHEC = Enterohemorrhagic, or Shiga toxin-producing Escherichia coli
30
HAV = Hepatitis A virus
31
HSP = Highly Susceptible Population
Guam Food Code Annex 1 – Public Health Reasons
46
No
No
1
2-201.12 Table 1b: Summary of Requirements for Diagnosed, Symptomatic Food
2
Employees
3
4
Food employees and conditional employees shall report a listed
5
diagnosis with symptoms immediately to the person in charge
6
The person in charge shall notify the RA when a food employee is jaundiced or
7
reports a listed diagnosis
8
The person in charge shall prohibit a conditional employee that reports a listed diagnosis with
9
symptoms from becoming a food employee until meeting the criteria listed in section 2-201.13 of the
10
Food Code, for reinstatement of a diagnosed, symptomatic food employee.
11
12
13
Diagnosis
14
15
EXCLUSION
Removing diagnosed, symptomatic
RA Approval
Facilities Serving HSP
food employees from exclusion
Needed to
or not Serving HSP
Return to
Work?
16
17
18
19
20
21
22
23
24
25
26
Hepatitis A
EXCLUDE if
When approval is obtained from the
virus
within 14 days
RA 2-201.13(B), and:
27
28
29
30
31
32
Typhoid Fever
EXCLUDE
When approval is obtained from the
(S. Typhi)
2-201.12(C)
RA 2-201.13(C)(1), and:
33
E. coli
of any symptom,
• The food employee has been jaundiced
or within 7 days
for more than 7 calendar days 2-201.13
of jaundice
(B)(1), or
2-201.12(B)(2)
Yes
• The anicteric food employee has had
symptoms or more than 14 days
2-201.13(B)(2), or
• The food employee provides medical
documentation 2-201.13(B)(3) (also see
Table 2).
Yes
• Food employee provides medical
documentation, that states the food
employee is free of a S. Typhi infection
2-201.13(C)(2) (also see Table 2).
EXCLUDE
1. Serving Non-HSP facility: 2-201.13(A)(4)(a):
Guam Food Code Annex 1 – Public Health Reasons
47
Yes to
1
O157:H7 or
Based on
Shall only work on a restricted basis 24
return to
2
other EHEC/
vomiting or
hours after symptoms resolve and remains
HSP or to
STEC
diarrhea
restricted until meeting the requirements
return
symptoms,
listed below:
unrestricted;
3
4
5
6
7
8
9
10
11
12
13
14
under
2-201.12(A)(2)
2. Serving HSP facility: 2-201.13(A)(4)(b):
Not required
Remains excluded until meeting the
to work on a
requirements listed below:
restricted
• Approval is obtained from RA 2-201.13(F),
basis in a
and
non-HSP
• Medically cleared 2-201.13(F)(1), or
facility
• More than 7 calendar days have passed
since the food employee became
asymptomatic 2-201.13(F)(2)
(also see Table 2).
15
(continued on next page)
Guam Food Code Annex 1 – Public Health Reasons
48
1
2-201.12 Table 1b: Summary of Requirements for Diagnosed, Symptomatic Food
2
Employees (continued)
3
4
5
Diagnosis
6
7
Removing diagnosed, symptomatic
RA Approval
Facilities Serving HSP
food employees from exclusion
Needed to
or not Serving HS
Return to
Work?
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
Norovirus
23
Shigella spp.
24
25
26
27
28
29
30
31
32
33
34
35
36
EXCLUSION
EXCLUDE
1. Serving Non-HSP facility: 2-201.13(A)(2)(a):
Yes to
Based on
Shall only work on a restricted basis 24
return to
vomiting or
hours after symptoms resolve and remains
HSP or to
diarrhea
restricted until meeting the requirements
return
symptoms,
listed below:
unrestricted;
under
2-201.12(A)(2)
2. Serving HSP facility: 2-201.13(A)(2)(b):
Not required
Remains excluded until meeting the
to work on a
requirements listed below:
restricted
• Approval is obtained from RA 2-201.13(D), basis in a
and
• Medically cleared 2-201.13(D)(1), or
non-HSP
facility
• More than 48 hours have passed
since the food employee became
asymptomatic 2-201.13(D)(2)
(also see Table 2).
EXCLUDE
1. Serving Non-HSP facility: 2-201.13(A)(3)(a):
Yes to
Based on
Shall only work on a restricted basis 24
return to
vomiting or
hours after symptoms resolve, and remains
HSP or to
diarrhea
restricted until meeting the requirements
return
symptoms,
listed below:
unrestricted;
under
2-201.12(A)(2)
2. Serving HSP facility: 2-201.13(A)(3)(b):
Not required
Remains excluded until meeting the
to work on a
requirements listed below:
restricted
• Approval is obtained from RA 2-201.13(E),
and
• Medically cleared 2-201.13(E)(1), or
• More than 7 calendar days have passed
since the food employee became
asymptomatic 2-201.13(E)(2)
Guam Food Code Annex 1 – Public Health Reasons
49
basis in a
non-HSP
facility
1
(also see Table 2).
Guam Food Code Annex 1 – Public Health Reasons
50
1
2-201.12 Table 2: Summary of Requirements for Diagnosed Food Employees with
2
Resolved Symptoms
3
4
Food employees and conditional employees shall report a
5
listed diagnosis immediately to the person in charge
6
The person in charge shall notify the RA when a food employee reports a listed diagnosis
7
The person in charge shall prohibit a conditional employee that reports a listed diagnosis from
8
becoming a food employee until meeting the criteria listed in section 2-201.13 of the Food Code, for
9
reinstatement of a diagnosed food employee.
10
11
Pathogen
12
Diagnosis
Facilities
Serving HSP
13
Facilities Not
Removing Diagnosed Food
Serving
Employees with Resolved
Return to
Symptoms from Exclusion
Work?
HSP
14
RA Approval
or Restriction
15
Typhoid
EXCLUDE
EXCLUDE
When approval is obtained from the RA
16
fever
2-201.12(C)
2-201.12(C)
2-201.13(C)(1), and:
17
(S. Typhi)
18
including
medical documentation, that
19
previous
states the food employee is free
20
illness
of a S. Typhi infection
21
with S.Typhi
2-201.13)(C)(2) (also see
22
(see 2-201.11
Table 1b).
23
(A)(3)
24
Shigella
EXCLUDE
RESTRICT
25
26
27
28
29
30
31
32
33
spp.
2-201.12(E)(1)
2-201.12(E)(2)
•
Yes
Food employee provides
1. Serving Non-HSP facility:
Yes to
2-201.13(A)(3)(a): Shall only work
return to
on a restricted basis 24 hours after
HSP or to
symptoms resolve, and remains
return
restricted until meeting the
unrestricted;
requirements listed below:
Not required
2. Serving HSP facility:
2-201.13(A)(3)(b): Remains
restricted
excluded until meeting the
basis in a
requirements listed below:
non-HSP
Guam Food Code Annex 1 – Public Health Reasons
51
to work on a
1
2
3
4
5
6
7
8
9
•
Approval is obtained from the
facility
RA 2-201.13(E), and:
•
Medically cleared
2-201.13(E)(1), or
•
More than 7 calendar days
have passed since the food
employee became
asymptomatic 2-201.13(E)(3)(a)
(also see Table 1b).
10
(continued on next page)
Guam Food Code Annex 1 – Public Health Reasons
52
1
2-201.12 Table 2: Summary of Requirements for Diagnosed Food Employees with
2
Resolved Symptoms (continued)
3
4
Pathogen
5
Diagnosis
Facilities
Serving HSP
6
Facilities Not
Removing Diagnosed Food
Serving
Employees with Resolved
Return to
HSP
Symptoms from Exclusion
Work?
7
8
RA Approval
or Restriction
Norovirus
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
EXCLUDE
RESTRICT
2-201.12(D)(1)
2-201.12(D)(2)
1. Serving Non-HSP facility:
Yes to
2-201.13(A)(2)(a): Shall only work
return to
on a restricted basis 24 hours after
HSP or to
symptoms resolve, and remains
return
restricted until meeting the
unrestricted;
requirements listed below:
Not required
2. Serving HSP facility:
to work on a
2-201.13(A)(2)(b): Remains
restricted
excluded until meeting the
basis in a
requirements listed below:
non-HSP
•
facility
Approval is obtained from the
RA 2-201.13(D), and:
•
Medically cleared
2-201.13(D)(1), or
passed since the food
employee became
asymptomatic 2-201.13(D)(2)
(also see Table 1b).
26
E. coli
EXCLUDE
RESTRICT
27
O157:H7
2-201.12(F)(1)
2-201.12(F)(2)
28
1. Serving Non-HSP facility:
Yes to
2-201.13(A)(4)(a): Shall only work
return to
or other
on a restricted basis 24 hours after
HSP or to
29
EHEC/
symptoms resolve, and remains
return
30
31
32
33
34
35
STEC
restricted until meeting the
unrestricted;
requirements listed below:
Not required
2. Serving HSP facility:
to work on a
2-201.13(A)(4)(b): Remains
restricted
excluded until meeting the
basis in a
requirements listed below:
non-HSP
Guam Food Code Annex 1 – Public Health Reasons
53
1
2
3
4
5
6
7
8
•
Approval is obtained from the
facility
RA 2-201.13(F), and:
•
Medically cleared
2-201.13(F)(1), or
•
More than 7 calendar days
have passed since the food
employee became
asymptomatic 2-201.13(F)(2).
9
(continued on next page)
Guam Food Code Annex 1 – Public Health Reasons
54
1
2-201.12 Table 2: Summary of Requirements for Diagnosed Food Employees with
2
Resolved Symptoms (continued)
3
4
Pathogen
Facilities
Facilities Not
5
Diagnosis
Serving HSP
Serving
Employees with Resolved
Return to
HSP
Symptoms from Exclusion
Work?
6
Removing Diagnosed Food
7
RA Approval
or Restriction
8
Hepatitis A EXCLUDE if
EXCLUDE if
9
virus
within 14 days
within 14 days of
10
of any
any symptom, or
• The food employee has been
11
symptom, or
within 7 days of
jaundiced for more than 7
12
within 7 days
jaundice
calendar days 2-201.13(B)(1), or
13
of jaundice
2-201.12(B)(2)
14
2-201.12(B)(2)
When approval is obtained from the RA
2-201.13(B), and:
• The anicteric food employee
has had symptoms for more
15
16
17
18
19
than 14 days 2-201.13(B)(2), or
• The food employee provides
medical documentation
2-201.13(B)(3) (see also
Table 1b).
Guam Food Code Annex 1 – Public Health Reasons
55
Yes
1
2-201.12 Table 3: Summary of Requirements for Diagnosed Food Employees Who
2
Never Develop Gastrointestinal Symptoms
3
4
Food employees and conditional employees shall report a listed
5
diagnosis immediately to the person in charge
6
The person in charge shall notify the RA when a food employee reports a listed diagnosis
7
The person in charge shall prohibit a conditional employee that reports a listed diagnosis from
8
becoming a food employee until meeting the criteria listed in section 2-201.13 of the Food Code, for
9
reinstatement of a diagnosed food employee
10
11
12
13
14
Pathogen
Facilities
Facilities Not
Diagnosis
Serving HSP
Serving
15
Typhoid
EXCLUDE
EXCLUDE
When approval is obtained from the RA
16
fever
2-201.12(C)
2-201.12(C)
2-201.13(C)(1), and:
17
(S. Typhi)
18
including
Food employee provides medical
19
previous
documentation, specifying that the food
20
illness
employee is free of a S. Typhi infection
21
with S.Typhi
2-201.13(C)(2).
22
(see 2-201.11
23
(A)(3))
24
Shigella
EXCLUDE
25
spp.
2-201.12(E)(1)2-201.12(E)(2)
26
27
28
29
30
31
32
33
HSP
Removing Diagnosed Food
Employees Who Never Develop
Gastrointestinal Symptoms
RA Approval
Return to
Work?
from Exclusion or Restriction
RESTRICT
Yes
Remains excluded or restricted until
Yes to return
approval is obtained from the RA, and:
to HSP or to
return
• Medically cleared 2-201.13(E)(1), or
unrestricted;
• More than 7 calendar days have
Not required
passed since the food employee was to work on a
last diagnosed 2-201.13(E)(3).
restricted
basis in a
non-HSP
facility
Guam Food Code Annex 1 – Public Health Reasons
56
1
2
3
4
5
6
7
8
9
10
Norovirus
EXCLUDE
RESTRICT
Remains excluded or restricted until
Yes to return
2-201.12(D)(1)
2-201.12(D)(2)
approval is obtained from the
to HSP or to
RA 2-201.13(D), and
return
unrestricted;
• Medically cleared 2-201.13(D)(1), or Not required
• More than 48 hours have passed
to work on a
since the food employee was
restricted
last diagnosed 2-201.13(D)(3).
basis in a
non-HSP
facility
11
(continued on next page)
Guam Food Code Annex 1 – Public Health Reasons
57
1
2-201.12 Table 3: Summary of Requirements for Diagnosed Food Employees Who
2
Never Develop Gastrointestinal Symptoms (continued)
3
4
5
6
7
Pathogen
Facilities
Facilities Not
Removing Diagnosed Food
RA Approval
Diagnosis
Serving HSP
Serving
Employees Who Never Develop
Return to
HSP
Gastrointestinal Symptoms
Work?
8
E. coli
9
O157:H7
from Exclusion or Restriction
10
or other
11
EHEC/
12
13
14
15
16
17
STEC
18
Hepatitis
19
A virus
EXCLUDE
2-201.12(F)(1)
RESTRICT
Remains excluded or restricted until
Yes to return
2-201.12(F)(2)
approval is obtained from the
to HSP or to
RA 2-201.13(F), and
return
unrestricted;
• Medically cleared 2-201.13(F)(1), or
Not required
• More than 7 calendar days have
to work on a
passed since the food employee was
restricted
last diagnosed 2-201.13(F)(3).
basis in a
non-HSP
facility
EXCLUDE
EXCLUDE
2-201.12(B)(3)
2-201.12(B)(3)
20
21
22
23
24
25
26
When approval is obtained from the RA
2-201.13(B), and
•
The anicteric food employee has
had symptoms for more than 14
days 2-201.13(B)(2), or
•
The food employee provides
medical documentation
2-201.13(B)(3).
27
28
29
Key for Tables 1, 2, 3, and 4:
30
RA = Regulatory Authority
31
EHEC = Enterohemorrhagic, or Shiga toxin-producing Escherichia coli
32
HAV = Hepatitis A virus
33
HSP = Highly Susceptible Population
Guam Food Code Annex 1 – Public Health Reasons
58
Yes
1
2
3
4
5
6
7
8
9
2-201.12 Table 4: History of Exposure, and Absent Symptoms or Diagnosis
Food employees and conditional employees shall report a listed exposure to the person in charge
The person in charge shall prohibit a conditional employee who reports a listed exposure from
becoming a food employee in a facility serving a HSP until meeting the criteria listed in section 2-201.13
of the Food Code, for reinstatement of an exposed food employee
The person in charge shall reinforce and ensure compliance with good hygienic practices, symptom reporting
requirements, proper handwashing and no BHC with RTE foods for all food employees that report a listed
exposure
10
11
Pathogen
Facilities
Diagnosis
Serving HSP
12
13
14
15
16
17
Typhoid
RESTRICT
Educate food employee
2-201.13(I)(3)
Fever
2-201.12(I)
on symptoms to watch
When 14 calendar days have passed
for and ensure
since the last exposure, or more than
compliance with GHP,
14 days has passed since the food
handwashing and no
employee‟s household contact
BHC with RTE foods.
became asymptomatic.
18
Shigella
RESTRICT
Educate food employee
2-201.13(I)(2)
19
20
21
22
23
spp.
2-201.12(I)
on symptoms to watch
When more than 3 calendar days
for and ensure
have passed since the last exposure,
compliance with GHP,
or more than 3 days have passed
handwashing and no
since the food employee‟s household
BHC with RTE foods.
contact became asymptomatic.
24
25
26
27
28
29
30
Norovirus
RESTRICT
Educate food employee
2-201.13(I)(1)
2-201.12(I)
on symptoms to watch
When more than 48 hours have
for and ensure
passed since the last exposure, or
compliance with GHP,
more than 48 hours has passed since
handwashing and no
the food employee‟s household
bare hand contact with
contact became asymptomatic
31
32
33
34
35
36
(S. Typhi)
Facilities Not Serving
HSP
When Can the Restricted
RA Approval
Food Employee Return Work?
needed
No
No
No
RTE foods.
E. coli
RESTRICT
Educate food employee
2-201.13(I)(2)
O157:H7 or
2-201.12(I)
on symptoms to watch
When more than 3 calendar days
other EHEC/
for and ensure
have passed since the last exposure,
STEC
compliance with GHP,
or more than 3 calendar days has
handwashing and no
passed since the food employee‟s
bare hand contact with
household contact became
Guam Food Code Annex 1 – Public Health Reasons
59
No
1
RTE foods.
asymptomatic.
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
Hepatitis A
RESTRICT
Educate food employee
2-201.13(I)(4)
virus
2-201.12(I)
on symptoms to watch
When any of the following conditions
for and ensure
is met:
compliance with GHP,
* The food employee is immune to
handwashing and no
HAV infection because of a prior
bare hand contact with
illness from HAV, vaccination against
RTE foods.
HAV, or IgG administration; or
18
Key for Table 4: GHP = Good Hygienic Practices; RTE = Ready-to-Eat foods; BHC = Bare Hand Contact
No
* More than 30 calendar days have
passed since the last exposure; or
since the food employee‟s household
contact became jaundiced; or
* The food employee does not use an
alternative procedure that allows BHC
with RTE food until at least 30 days
after the potential exposure, and the
employee receives additional training
Guam Food Code Annex 1 – Public Health Reasons
60
2-201.12
1
Exclusion and Restrictions (continued)3
2
Restrictions and exclusions vary according to the population served because highly
3
susceptible populations have increased vulnerability to foodborne illness. For
4
example, foodborne illness in a healthy individual may be manifested by mild flu-like
5
symptoms. The same foodborne illness may have serious medical consequences
6
in immunocompromised individuals. This point is reinforced by statistics pertaining
7
to deaths associated with foodborne illness caused by Salmonella Enteritidis.
8
Over 70% of the deaths in outbreaks attributed to this organism occurred among
9
individuals who for one reason or another were immunocompromised. This is why
10
the restrictions and exclusions listed in the Code are especially stringent for food
11
employees serving highly susceptible populations.
12
Periodic testing of food employees for the presence of diseases transmissible
13
through food is not cost effective or reliable. Therefore, restriction and exclusion
14
provisions are triggered by the active gastrointestinal symptoms, followed by
15
diagnosis and history of exposure.
16
The history of exposure that must be reported applies only to the 5 organisms
17
listed. Upon being notified of the history of exposure, the person in charge should
18
immediately:
19
1.
Discuss the traditional modes of transmission of fecal-oral route pathogens.
20
2.
Advise the food employee to observe good hygienic practices both at home
21
and at work.
22
described in the Code, after going to the bathroom, changing diapers, or
23
handling stool-soiled material.
24
3.
25
This includes a discussion of proper handwashing, as
Review the symptoms listed in the Code that require immediate exclusion
from the food establishment.
3
In order to comply with Title I of the Americans with Disabilities Act, an exclusion must also be removed if the employee
is entitled to a reasonable accommodation that would eliminate the risk of transmitting the disease. Reasonable
accommodation may include reassignment to another position in which the individual would not work around food. The
steps an employer must take when an excluded employee requests reasonable accommodation are briefly described in
Annex 3, § 2-201.11. However, it is not possible to explain all relevant aspects of the ADA within this Annex. When
faced with an apparent conflict between the ADA and the Food Code‟s exclusion and restriction requirements, employers
should contact the U.S. Equal Employment Opportunity Commission.
Guam Food Code Annex 1 – Public Health Reasons
61
1
4.
Remind food employees of their responsibility as specified in the Code to
2
inform the person in charge immediately upon the onset of any of the
3
symptoms listed in the Code.
4
5.
Ensure that the food employee stops work immediately if any of the
5
symptoms described in the Code develop and reports to the person in
6
charge.
7
A restricted food employee may work in an area of the food establishment that
8
houses packaged food, wrapped single-service or single-use articles, or soiled food
9
equipment or utensils. Examples of activities that a restricted person might do
10
include working at the cash register, seating patrons, bussing tables, stocking
11
canned or other packaged foods, or working in a non-food cleaning or maintenance
12
capacity consistent with the criteria in the definition of the term “restricted.” A food
13
employee who is restricted from working in one food establishment may not work in
14
an unrestricted capacity in another food establishment, but could work unrestricted
15
in another retail store that is not a food establishment. A restricted food employee
16
may enter a food establishment as a consumer.
17
An excluded individual may not work as a food employee on the premises of any
18
food establishment.
2-201.13
19
Removal of Exclusions and Restrictions.4
20
Food employees diagnosed with Norovirus, hepatitis A virus, Shigella spp., E. coli
21
O157:H7 or other EHEC, and symptomatic with diarrhea, vomiting, or jaundice, are
22
excluded under subparagraph 2-201.12 (A)(2) or 2-201.12(B)(2). owever, these
23
symptomatic, diagnosed food employees differ from symptomatic, undiagnosed food
24
employees in the requirements that must be met before returning to work in a full
25
capacity after symptoms resolve.
4
In order to comply with Title I of the Americans with Disabilities Act, an exclusion must also be removed if the employee
is entitled to a reasonable accommodation that would eliminate the risk of transmitting the disease. Reasonable
accommodation may include reassignment to another position in which the individual would not work around food. The
steps an employer must take when an excluded employee requests reasonable accommodation are briefly described in
Annex 3, § 2-201.11. However, it is not possible to explain all relevant aspects of the ADA within this Annex. When
faced with an apparent conflict between the ADA and the Food Code‟s exclusion and restriction requirements, employers
should contact the U.S. Equal Employment Opportunity Commission.
Guam Food Code Annex 1 – Public Health Reasons
62
1
The person in charge may allow undiagnosed food employees who are initially
2
symptomatic and whose symptoms have resolved to return to work in a full capacity
3
24 hours after symptoms resolve.
4
However, diagnosis with a listed pathogen invokes additional requirements before
5
the person in charge may allow diagnosed food employees to return to work in full
6
capacity.
7
Asymptomatic food employees diagnosed with Norovirus, Shigella spp., E. coli
8
O157:H7 or other EHEC may not return to work in a full capacity for at least 24
9
hours after symptoms resolve. The person in charge shall only allow these food
10
employees to work on a restricted basis 24 hours after symptoms resolve and they
11
shall only allow this if not in a food establishment that serves a highly susceptible
12
population. These restricted food employees remain restricted until they are
13
medically cleared or otherwise meet the criteria for removal from restriction as
14
specified under subparagraphs 2-201.13(D) (1)-(2); 2-201.13(E)(1)-(2); or 2-
15
201.13(F)(1)-(2).
16
In a food establishment that serves a highly susceptible population, food employees
17
who are diagnosed with Norovirus, Shigella spp., E. coli O157:H7 or other EHEC
18
and initially symptomatic with vomiting or diarrhea, shall not work on a restricted
19
basis after being asymptomatic for at least 24 hours. These food employees must
20
remain excluded until they are medically cleared or otherwise meet the criteria for
21
removal from exclusion from a highly susceptible population under subparagraph 2-
22
201.13(D) (1)-(2), 2-201.13(E)(1)-(2), or 2-201.13 (F)(1)-(2).
23
Food employees diagnosed with hepatitis A virus are always excluded if
24
diagnosed within 14 days of exhibiting any illness symptom, until at least 7 days
25
after the
26
subparagraphs 2-201.13(B)(1)-(4).
27
Food employees diagnosed with hepatitis A virus are always excluded if
28
diagnosed within 14 days of exhibiting any illness symptom, until at least 7 days
29
after the onset of jaundice, or until medically cleared as specified under
30
subparagraph 2-201.13(B)(1)-(3). A food employee with an anicteric infection with
onset of jaundice, or until medically cleared as specified under
Guam Food Code Annex 1 – Public Health Reasons
63
1
the hepatitis A virus has a mild form of hepatitis A without jaundice.
2
employees diagnosed with an anicteric infection with the hepatitis A virus are
3
excluded if they are within 14 days of any symptoms. Anicteric, diagnosed food
4
employees shall be removed from exclusion if more than 14 days have passed
5
since they became symptomatic, or if medically cleared.
6
employees diagnosed with an active infection with the hepatitis A virus are also
7
excluded until medically cleared.
8
Hands and Arms
9
The hands are particularly important in transmitting foodborne pathogens. Food
10
employees with dirty hands and/or fingernails may contaminate the food being
11
prepared. Therefore, any activity which may contaminate the hands must be
12
followed by thorough handwashing in accordance with the procedures outlined in
13
the Code.
14
Even seemingly healthy employees may serve as reservoirs for pathogenic
15
microorganisms that are transmissible through food. Staphylococci, for example,
16
can be found on the skin and in the mouth, throat, and nose of many employees.
17
The hands of employees can be contaminated by touching their nose or other
18
body parts.
19
2-301.11
Food
Asymptomatic food
Clean Condition.*
2-301.12
Cleaning Procedure.*
20
Handwashing is a critical factor in reducing fecal-oral pathogens that can be
21
transmitted from hands to RTE food as well as other pathogens that can be
22
transmitted from environmental sources. Many employees fail to wash their hands
23
as often as necessary and even those who do may use flawed techniques.
24
In the case of a food worker with one hand or a hand-like prosthesis, the Equal
25
Employment Opportunity Commission has agreed that this requirement for thorough
26
handwashing can be met through reasonable accommodation in accordance with
27
the Americans with Disabilities Act. Devices are available which can be attached to
28
a lavatory to enable the food worker with one hand to adequately generate the
29
necessary friction to achieve the intent of this requirement.
Guam Food Code Annex 1 – Public Health Reasons
64
1
The greatest concentration of microbes exists around and under the fingernails of
2
the hands. The area under the fingernails, known as the “subungal space,” has by
3
far the largest concentration of microbes on the hand and this is also the most
4
difficult area of the hand to decontaminate. Fingernail brushes, if used properly,
5
have been found to be effective tools in decontaminating this area of the hand.
6
Proper use of single-use fingernail brushes, or designated individual fingernail
7
brushes for each employee, during the handwashing procedure can achieve up to a
8
5-log reduction in microorganisms on the hands.
9
There are two different types of microbes on the hands, transient and resident
10
microbes.
Transient microbes consist of contaminating pathogens which are
11
loosely attached to the skin surface and do not survive or multiply. A moderate
12
number of these organisms can be removed with adequate handwashing. Resident
13
microbes consist of a relatively stable population that survive and multiply on the
14
skin and they are not easily washed off the hands. Resident microbes on the
15
hands are usually not a concern for potential contamination in food service.
16
All aspects of proper handwashing are important in reducing microbial transients
17
on the hands. However, friction and water have been found to play the most
18
important role. This is why the amount of time spent scrubbing the hands is critical
19
in proper handwashing. It takes more than just the use of soap and running water
20
to remove the transient pathogens that may be present. It is the abrasive action
21
obtained by vigorously rubbing the surfaces being cleaned that loosens the
22
transient microorganisms on the hands.
23
Research has shown a minimum 10-15 second scrub is necessary to remove
24
transient pathogens from the hands and when an antimicrobial soap is used, a
25
minimum of 15 seconds is required. Soap is important for the surfactant effect in
26
removing soil from the hands and a warm water temperature is important in
27
achieving the maximum surfactant effect of the soap.
28
Every stage in handwashing is equally important and has an additive effect in
29
transient microbial reduction. Therefore, effective handwashing must include
30
scrubbing, rinsing, and drying the hands. When done properly, each stage of
Guam Food Code Annex 1 – Public Health Reasons
65
1
handwashing further decreases the transient microbial load on the hands. It is
2
equally important to avoid recontaminating hands by avoiding direct hand contact
3
with heavily contaminated environmental sources, such as manually operated
4
handwashing sink faucets, paper towel dispensers, and rest room door handles
5
after the handwashing procedure. This can be accomplished by obtaining a paper
6
towel from its dispenser before the handwashing procedure, then, after
7
handwashing, using the paper towel to operate the hand sink faucet handles and
8
restroom door handles.
9
Handwashing done properly can result in a 2-3 log reduction in transient bacteria
10
and a 2-log reduction in transient viruses and protozoa. With heavy contamination
11
of
12
contaminated with bodily wastes and infected bodily fluids) handwashing may be
13
ineffective in completely decontaminating the hands.
14
intervention such as a barrier between hands and ready-to-eat food is necessary.
15
transient
microbial pathogens, (i.e., > 104 microbes, as found on hands
2-301.13
Therefore,
a further
Special Handwash Procedures.*
16
This section is reserved.
17
In earlier editions of the Code, FDA's model contained a provision for a Special
18
Procedure in certain situations. Pursuant to a 1996 Conference for Food Protection
19
(CFP) Recommendation, the text of this Code provision is removed and the section
20
is reserved. It is FDA's intent to further research the matter and to submit the
21
findings to the CFP for reconsideration of the matter.
22
2-301.14
When to Wash.*
23
The hands may become contaminated when the food employee engages in specific
24
activities. The increased risk of contamination requires handwashing immediately
25
after the activities listed. The specific examples listed in this Code section are not
26
intended to be all inclusive. Employees must wash their hands after any activity
27
which may result in contamination of the hands.
28
2-301.15
Where to Wash.
29
Effective handwashing is essential for minimizing the likelihood of the hands
30
becoming a vehicle of cross contamination. It is important that handwashing be
Guam Food Code Annex 1 – Public Health Reasons
66
1
done only at a properly equipped handwashing facility in order to help ensure that
2
food employees effectively clean their hands.
3
conveniently located, always accessible for handwashing, maintained so they
4
provide proper water temperatures and pressure, and equipped with suitable hand
5
cleansers, nail brushes, and disposable towels and waste containers, or hand
6
dryers. It is inappropriate to wash hands in a food preparation sink since this may
7
result in avoidable contamination of the sink and the food prepared therein.
8
Service sinks may not be used for food employee handwashing since this practice
9
may introduce additional hand contaminants because these sinks may be used for
10
the disposal of mop water, toxic chemicals, and a variety of other liquid wastes.
11
Such wastes may contain pathogens from cleaning the floors of food preparation
12
areas and toilet rooms and discharges from ill persons.
2-301.16
13
Handwashing sinks are to be
Hand Antiseptics.
14
In the 2005 Food Code, the use of the term “hand sanitizer” was replaced by the
15
term “hand antiseptic” to eliminate confusion with the term “sanitizer,” a defined
16
term in the Food Code, and to more closely reflect the terminology used in the FDA
17
Tentative Final Monograph for Health-Care Antiseptic Drug Products for OTC
18
Human Use, Federal Register: June 17, 1994.
19
The term “sanitizer” is typically used to describe control of bacterial contamination
20
of inert objects or articles, or equipment and utensils, and other cleaned food-
21
contact surfaces. The Food Code definition of “sanitizer” requires a minimum
22
microbial reduction of 5 logs, which is equal to a 99.999% reduction. The FDA
23
bases the 5-log reduction on the AOAC International‟s “Official Methods of Analysis
24
2003,” which requires a minimum 5-log reduction in microorganisms to achieve
25
“sanitization.”
26
Sanitizers used to disinfect food-contact equipment and utensils can easily achieve
27
the 5-log reduction of microorganisms and often far exceed this minimum
28
requirement. However, removing microorganisms from human skin is a totally
29
different process and sterilization of human skin is nearly impossible to achieve
30
without damaging the skin. Many antimicrobial hand agents typically achieve a
Guam Food Code Annex 1 – Public Health Reasons
67
1
much smaller reduction in microorganisms than the 5-log reduction required for
2
“sanitization.” Therefore, the effect achieved from using antimicrobial hand
3
agents is not consistent with the definition of “sanitization” in the Food Code.
4
The word “antiseptic” is a Greek term, meaning “against putrefaction,” and
5
eventually evolved into a second definition, meaning, “a substance used to destroy
6
pathogenic microorganisms.” The term “antiseptic” is often used to describe agents
7
used on skin to prevent infection of the skin.
8
“Antiseptic” is defined under section 201 (o) of the Federal Food, Drug, and
9
Cosmetic Act (the act) (21 U.S.C. 321 (o), as: “The representation of a drug, in its
10
labeling, as an antiseptic shall be considered to be a representation of a germicide,
11
except in the case of a drug purporting to be, or represented as, an antiseptic for
12
inhibitory use as a wet dressing, ointment, dusting powder, or such other use as
13
involves prolonged contact with the body.”
14
Section 333.403 of the FDA Tentative Final Monograph for Health-Care Antiseptic
15
Drug Products for OTC Human Use, Federal Register: June 17, 1994, defines a
16
“health-care antiseptic” as an antiseptic-containing drug product applied topically to
17
the skin to help prevent infection or to help prevent cross contamination. An
18
“antiseptic handwash” or “health-care personnel handwash drug product” is
19
defined in Section 333.403 of the Monograph as an antiseptic containing
20
preparation designed for frequent use; it reduces the number of transient
21
microorganisms on intact skin to an initial baseline level after adequate washing,
22
rinsing, and drying; it is a broad spectrum, and persistent antiseptic containing
23
preparation that significantly reduces the number of microorganisms on intact skin.
24
Replacing the term “hand sanitizer” with the term “hand antiseptic” allows the use of
25
a more scientifically appropriate term that is used to describe reduction of
26
microorganisms on the skin and will improve clarification and regulation of these
27
products.
28
The provisions of § 2-301.16 are intended to ensure that an antimicrobial
29
product applied to the hands is 1) safe and effective when applied to human skin,
30
and 2) a safe food additive when applied to bare hands that will come into direct
Guam Food Code Annex 1 – Public Health Reasons
68
1
contact with food. Because of the need to protect workers and to ensure safe food,
2
hand antiseptics must comply with both the human drug and the food safety
3
provisions of the law. The prohibition against bare hand contact contained in 3-
4
301.11(B) applies only to an exposed ready-to-eat food.
5
As a Drug Product
6
There are two means by which a hand antiseptic is considered to be safe and
7
effective when applied to human skin:
8
1. A hand antiseptic may be approved by FDA under a new drug application
9
based on data showing safety and effectiveness and may be listed in the
10
publication Approved Drug Products with Therapeutic Equivalence
11
Evaluations.
12
Administration, Center for Drug Evaluation and Research, Office of
13
Pharmaceutical Science, Office of Generic Drugs. Also known as the
14
“Orange Book,” this document provides “product-specific” listings rather than
15
listings by compound. It is published annually with monthly supplements and
16
is available at http://www.fda.gov/cder/ob/default.htm. However, as of the
17
end of 1998, no hand antiseptics are listed in this publication since no new
18
drug applications have been submitted and approved for these products.
19
2. A hand antiseptic active ingredient may be identified by FDA in the
20
monograph for OTC (over-the-counter) Health-Care Antiseptic Drug Products
21
under the antiseptic handwash category. Since hand anti septic products
22
are intended and labeled for topical antimicrobial use by food employees in
23
the prevention of disease in humans, these products are “drugs” under the
24
Federal Food, Drug, and Cosmetic Act § 201(g). As drugs, hand antiseptics
25
and dips must be manufactured by an establishment that is duly registered
26
with the FDA as a drug manufacturer; their manufacturing, processing,
27
packaging, and labeling must be performed in conformance with drug Good
28
Manufacturing Practices (GMP's); and the product must be listed with FDA
29
as a drug product.
This document is maintained by the Food and
Guam Food Code Annex 1 – Public Health Reasons
69
Drug
1
Products having the same formulation, labeling, and dosage form as those that
2
existed in the marketplace on or before December 4, 1975, for hand antiseptic use
3
by food handlers, are being evaluated under the Over-the-Counter (OTC) Drug
4
Review by FDA‟s Center for Drug Evaluation and Research. However, as of May
5
2005, a final OTC drug monograph for these products has not been finalized.
6
Therefore, FDA has not made a final determination that any of these products are
7
generally recognized as safe and effective (GRAS/E).
8
GRAS/E antimicrobial ingredients for hand sanitizer use by food handlers will be
9
identified in a future final monograph issued under the OTC Drug Review.
10
Information about whether a specific product is covered by the proposed
11
monograph may be obtained from the tentative final monograph (TFM) for “Health
12
Care Antiseptic Drug Products for OTC Human Use; Proposed Rule.” This TFM,
13
which was published in the Federal Register of June 17, 1994 (59 FR 31402),
14
describes the inclusion of hand sanitizers in this Review on page 31440 under
15
Comment 28 of Part II. Information about whether a specific product is included in
16
this proposed monograph may also be available from the manufacturer.
17
Questions regarding acceptability of a hand antiseptic with respect to OTC
18
compliance may be directed to the Division of New Drugs and Labeling Compliance
19
(HFD-310), Office of Compliance, Center for Drug Evaluation and Research, Food
20
and Drug Administration, 11919 Rockville Pike, Rockville, MD 20852. Specific
21
product label/promotional information and
22
determining a product‟s regulatory status.
23
As a Food Additive
24
To be subject to regulation under the food additive provisions of the Federal Food,
25
Drug, and Cosmetic Act, the substances in a hand antiseptic must reasonably be
26
expected to become a component of food based upon the product‟s intended use.
27
Where the substances in a hand antiseptic are reasonably expected to become a
28
component of food based upon the product‟s intended use, circumstances under
29
which those substances may be legally used include the following:
30
1.
the formulation are required for
The intended use of a substance may be exempted from regulation
Guam Food Code Annex 1 – Public Health Reasons
70
1
as a food additive under 21 CFR 170.39. Threshold of regulation for
2
substances used in food-contact articles. A review by FDA‟s Center for Food
3
Safety and Applied Nutrition is required in order to determine whether such
4
an exemption can be granted.
5
2.
A substance may be regulated for the intended use as a food additive under
6
21 CFR 174 – Indirect Food Additives – General, and be listed along with
7
conditions of safe use in 21 CFR 178 – Indirect Food Additives: Adjuvants,
8
Production Aids, and Sanitizers.
9
3.
The intended use of a substance, including substances that contact food
10
such as those in hand antiseptics, may be “generally recognized as safe
11
(GRAS)” within the meaning of the FFDCA. A partial listing of substances
12
with food uses that are generally recognized as safe may be found in CFR
13
Parts 182, 184, and 186. These lists are not exhaustive because the FFDCA
14
allows for independent GRAS determinations.
15
For the use of a substance to be GRAS within the meaning of the FFDCA,
16
there must be publicly available data that demonstrate that the substance is
17
safe for its intended use. There also must be a basis to conclude that there
18
is a consensus among qualified experts that these publicly available data
19
establish safety. If the use of a substance in food is GRAS, it is not subject
20
to premarket review by FDA. While there is no legal requirement to notify
21
FDA of an independent GRAS determination, a number of firms have chosen
22
to do so with the expectation of receiving a response letter from FDA (see
23
FDA‟s Inventory of GRAS Notices at http://www.cfsan.fda.gov/~rdb/opa-
24
gras.html. Although such a letter does not affirm the independent GRAS
25
determination, it is an opportunity for the firm to receive comment from FDA
26
regarding the materials supporting its determination.
27
4.
A substance may be the subject of a Food Contact Substance Notification
28
that became effective in accordance with the FFDCA Section 409 (h).
29
Substances that are the subject of an effective food-contact substance
30
notification are listed, along with conditions of safe use, in the FDA Inventory
Guam Food Code Annex 1 – Public Health Reasons
71
1
of Effective Premarket Notifications for Food Contact Substances. This list
2
is available on-line at http://www.cfsan.fda.gov/~dms/opa-fcn.html. A food-
3
contact substance that is the subject of an effective notification submitted
4
under FFDCA 409(h) does not include similar or identical substances
5
manufactured or prepared by any person other than the manufacturer
6
identified in that notification.
7
The Division of Food Contact Substance Notifications does not certify or provide
8
approvals for specific products. However, if the intended use of a substance in
9
contact with food meets the requirements of 21 CFR 170.39 Threshold of regulation
10
for substances used in food-contact articles, FDA may provide a letter to a firm
11
stating that the intended use of this product is exempt from regulation as a food
12
additive. However, the product must be the subject of a new drug application or
13
under FDA‟s OTC Drug Review to be legally marketed.
14
Questions regarding the regulatory status of substances in hand antiseptics as food
15
additives may be directed to the Division of Food Contact Substance Notifications,
16
HFS-275, 5100 Paint Branch Parkway, College Park, MD 20740. It may be helpful
17
or necessary to provide label/promotional information when inquiring about a
18
specific substance.
19
Fingernails
20
The requirement for fingernails to be trimmed, filed, and maintained is designed to
21
address both the cleanability of areas beneath the fingernails and the possibility
22
that fingernails or pieces of the fingernails may end up in the food due to breakage.
23
Failure to remove fecal material from beneath the fingernails after defecation can
24
be a major source of pathogenic organisms.
25
cleanability concerns and may harbor pathogenic organisms.
26
Jewelry
27
Items of jewelry such as rings, bracelets, and watches may collect soil and the
28
construction of the jewelry may hinder routine cleaning. As a result, the jewelry may
29
act as a reservoir of pathogenic organisms transmissible through food.
2-302.11
Maintenance.
2-303.11
Ragged fingernails present
Prohibition.
Guam Food Code Annex 1 – Public Health Reasons
72
1
The term “jewelry” generally refers to the ornaments worn for personal adornment
2
and medical alert bracelets do not fit this definition. However, the wearing of such
3
bracelets carries the same potential for transmitting disease-causing organisms to
4
food. If a food worker wears a medical alert or medical information bracelet, the
5
conflict between this need and the Food Code‟s requirements can be resolved
6
through reasonable accommodation in accordance with the Americans with
7
Disabilities Act. The person in charge should discuss the Food Code requirement
8
with the employee and together they can work out an acceptable alternative to a
9
bracelet. For example, the medical alert information could be worn in the form of a
10
necklace or anklet to provide the necessary medical information without posing a
11
risk to food. Alternatives to medical alert bracelets are available through a number
12
of different companies (e.g., an internet search using the term “medical alert
13
jewelry” leads to numerous suppliers).
14
An additional hazard associated with jewelry is the possibility that pieces of the item
15
or the whole item itself may fall into the food being prepared. Hard foreign objects
16
in food may cause medical problems for consumers, such as chipped and/or broken
17
teeth and internal cuts and lesions.
18
Outer Clothing
19
Dirty clothing may harbor diseases that are transmissible through food. Food
20
employees who inadvertently touch their dirty clothing may contaminate their hands.
21
This could result in contamination of the food being prepared. Food may also be
22
contaminated through direct contact with dirty clothing. In addition, employees
23
wearing dirty clothes send a negative message to consumers about the level of
24
sanitation in the establishment.
25
Food
26
Contamination
27
Prevention
2-304.11
2-401.11
Clean Condition.
Eating, Drinking, or Using Tobacco.*
Guam Food Code Annex 1 – Public Health Reasons
73
1
Proper hygienic practices must be followed by food employees in performing
2
assigned duties to ensure the safety of the food, prevent the introduction of foreign
3
objects into the food, and minimize the possibility of transmitting disease through
4
food. Smoking or eating by employees in food preparation areas is prohibited
5
because of the potential that the hands, food, and food-contact surfaces may
6
become contaminated. Insanitary personal practices such as scratching the head,
7
placing the fingers in or about the mouth or nose, and indiscriminate and uncovered
8
sneezing or coughing may result in food contamination. Poor hygienic practices by
9
employees may also adversely affect consumer confidence in the establishment.
10
Food preparation areas such as hot grills may have elevated temperatures and the
11
excessive heat in these areas may present a medical risk to the workers as a result
12
of dehydration. Consequently, in these areas food employees are allowed to drink
13
from closed containers that are carefully handled.
2-401.12
14
Discharges from the Eyes, Nose, and Mouth.*
15
Discharges from the eyes, nose, or mouth through persistent sneezing or coughing
16
by food employees can directly contaminate exposed food, equipment, utensils,
17
linens, and single-service and single-use articles. When these poor hygienic
18
practices cannot be controlled, the employee must be assigned to duties that
19
minimize the potential for contaminating food and surrounding surfaces and
20
objects.
21
Hair Restraints
22
Consumers are particularly sensitive to food contaminated by hair. Hair can be both
23
a direct and indirect vehicle of contamination. Food employees may contaminate
24
their hands when they touch their hair. A hair restraint keeps dislodged hair from
25
ending up in the food and may deter employees from touching their hair.
2-402.11
Effectiveness.
Guam Food Code Annex 1 – Public Health Reasons
74
2-403.11
Handling Prohibition.*
1
Animals
2
Dogs and other animals, like humans, may harbor pathogens that are transmissible
3
through food. Handling or caring for animals that may be legally present is
4
prohibited because of the risk of contamination of food employee hands and
5
clothing.
6
Chapter 3 Food
7
8
Condition
9
Sources
3-101.11
Safe, Unadulterated, and Honestly
Presented.*
10
3-201.11
Compliance with Food Law.*
11
Refer to the public health reason for § 3-401.11.
12
Source
13
A primary line of defense in ensuring that food meets the requirements of
14
§ 3-101.11 is to obtain food from approved sources, the implications of which are
15
discussed below. However, it is also critical to monitor food products to ensure that,
16
after harvesting and processing, they do not fall victim to conditions that endanger
17
their safety, make them adulterated, or compromise their honest presentation. The
18
regulatory community, industry, and consumers should exercise vigilance in
19
controlling the conditions to which foods are subjected and be alert to signs of
20
abuse. FDA considers food in hermetically sealed containers that are swelled or
21
leaking to be adulterated and actionable under the Federal Food, Drug, and
22
Cosmetic Act. Depending on the circumstances, rusted and pitted or dented cans
23
may also present a serious potential hazard.
24
Food, at all stages of production, is susceptible to contamination. The source of
25
food is important because pathogenic microorganisms may be present in the
26
breeding stock of farm animals, in feeds, in the farm environment, in waters used for
27
raising and freezing aquatic foods, and in soils and fertilizers in which plant crops
28
are grown. Chemical contaminants that may be present in field soils, fertilizers,
29
irrigation water, and fishing waters can be incorporated into food plants and
30
animals.
Guam Food Code Annex 1 – Public Health Reasons
75
1
Sources of molluscan shellfish are a particular concern because shellfish are
2
frequently consumed raw or in an undercooked state and thus receive neither heat
3
treatment nor any other process that would destroy or inactivate microbial
4
pathogens. For safety, these foods must be accompanied by certification that
5
documents that they have been harvested from waters that meet the water quality
6
standards contained in the National Shellfish Sanitation Program Guide for the
7
Control of Molluscan Shellfish.
8
processing, packaging, and shipping have been conducted under sanitary
9
conditions.
Certification also provides confidence that
10
Food should be purchased from commercial supplies under regulatory control.
11
Home kitchens, with their varieties of food and open entry to humans and pet
12
animals, are frequently implicated in the microbial contamination of food. Because
13
commercial items seldom are eaten right away, the home kitchen's limited capacity
14
for maintaining food at proper temperatures may result in considerable microbial
15
growth and toxin production by microorganisms introduced through the diverse
16
sources of contamination.
17
preparation of food entering commerce.
18
Labeling – General
19
Sources of packaged food must be labeled in accordance with law. Proper labeling
20
of foods allows consumers to make informed decisions about what they eat. Many
21
consumers, as a result of an existing medical condition, may be sensitive to specific
22
foods or food ingredients.
23
consequences should certain foods or ingredients be unknowingly consumed. In
24
addition, consumers have a basic right to be protected from misbranding and fraud.
25
Except for certain species of large tuna and raw molluscan shellfish, if fish are
26
intended for raw consumption, they must be properly frozen before they are served.
27
If this process is done off-premises, purchase specifications ensuring that proper
28
freezing techniques are used to destroy parasites must be provided. Labeling
29
should accompany the product to advise as to whether the product was frozen
30
properly. This is necessary because fish from natural bodies of water may carry
Controlled processing is required for the safe
This sensitivity may result in dangerous medical
Guam Food Code Annex 1 – Public Health Reasons
76
1
parasitic worms that can infect and injure consumers who eat such raw fish dishes
2
as sushi, ceviche, green (lightly marinated) herring, and cold-smoked salmon. The
3
worms are often deeply imbedded inside fish muscle. Thorough freezing kills these
4
worms if the fish are subjected to a low enough temperature for a long enough
5
time.
6
Labeling for Fish
7
Except for certain species of large tuna and raw molluscan shellfish, if fish are
8
intended for raw consumption, they must be properly frozen before they are
9
served. If this process is done off-premises, purchase specifications ensuring that
10
proper freezing techniques are used to destroy parasites must be provided.
11
Labeling or other information should accompany the product to advise as to
12
whether the product was frozen properly. This is necessary because fish from
13
natural bodies of water may carry parasitic worms that can infect and injure
14
consumers who eat such raw fish dishes as sushi, ceviche, green (lightly
15
marinated) herring, and cold-smoked salmon.
16
imbedded inside fish muscle. Thorough freezing kills these worms if the fish are
17
subjected to a low enough temperature for a long enough time.
18
Labeling for Juice
19
On July 8, 1998, FDA announced in the Federal Register a final rule that revised
20
its food labeling regulations to require a warning statement on fruit and vegetable
21
juice products that have not been processed to prevent, reduce, or eliminate
22
pathogenic microorganisms that may be present. FDA took this action to inform
23
consumers, particularly those at greatest risk, of the hazard posed by such juice
24
products. FDA expects that providing this information to consumers will allow them
25
to make informed decisions on whether to purchase and consume such juice
26
products, thereby reducing the incidence of foodborne illnesses and deaths caused
27
by the consumption of these juices.
28
On July 18, 2001, FDA announced a final rule designed to improve the safety of
29
fruit and vegetable juice and juice products. Under the rule, juice processors must
30
use Hazard Analysis and Critical Control Point (HACCP) principles for juice
The worms are often deeply
Guam Food Code Annex 1 – Public Health Reasons
77
1
processing. Processors making shelf-stable juices or concentrates that use a single
2
thermal processing step are exempt from the microbial hazard requirements of the
3
HACCP regulation. Retail establishments where packaged juice is made and only
4
sold directly to consumers (such as juice bars) are not required to comply with this
5
regulation.
6
Rather, the Food Code requires fresh fruit or vegetable juices that are packaged at
7
retail (untreated juices or beverages containing untreated juices that are offered to
8
consumers as prepackaged foods) to be processed under HACCP with a 5 log
9
reduction in pathogens of concern OR bear the warning statement as specified in
10
21 CFR Section 101.17(g). That statement is: “WARNING: This product has not
11
been pasteurized and, therefore, may contain harmful bacteria that can cause
12
serious illness in children, the elderly, and persons with weakened immune
13
systems.” Refer to Chapter 1 for the definition of juice. It is important to note that
14
the definition of “juice” includes puréed fruits and vegetables, which are commonly
15
prepared for service to highly susceptible populations.
16
Food establishments that serve a highly susceptible population (HSP) cannot serve
17
prepackaged juice that bears the warning label and they must serve only
18
pasteurized juice. For juice only, this population includes children who are age 9 or
19
less and receive food in a school, day care setting, or similar facility that provides
20
custodial care.
21
Unpackaged juice (glasses of juice prepared at a juice bar, for example) does not
22
require the 5 log reduction nor a warning statement or other consumer advisory
23
(juice is not an animal food and therefore not covered by section 3-603.11) when
24
prepared and served at retail. Usually the juice is served by the glass or in small
25
batches compared to a commercial juice processor. The risk of using “drops” and
26
damaged fruits or vegetables is much less at retail because of buyer specs that
27
provide higher quality produce, meaning that fruits for juicing are less likely to be of
28
a lower quality or damaged.
29
Additional information is available in the document, “Guidance for Industry.
30
Warning and Notice Statement: Labeling of Juice Products, Small Entity
Guam Food Code Annex 1 – Public Health Reasons
78
1
Compliance
Guide”
which
can
be
found
on
2
http://www.cfsan.fda.gov/~dms/juicguid.html or obtained from the FDA Office of
3
Nutritional Products Labeling and Dietary Supplements.
4
Labeling for Meat and Poultry
5
Retail food establishments that process and package meat or poultry in a form that
6
is not ready-to-eat, are obligated by Federal regulation to label the product with
7
safe food handling instructions. The intent of this requirement is to ensure that all
8
consumers are alerted to the fact that such products may contain bacteria and that
9
food safety hinges upon their thoroughly cooking the product, regardless of where
10
they obtain the products. That is, the labeling would exist if they obtain their meat
11
and poultry at an establishment that handles only prepackaged and prelabeled
12
products or if they obtain their meat or poultry at an operation such as a
13
supermarket with a meat processing operation or from a small neighborhood
14
butcher.
15
Labeling Guidance for Irradiated Raw Meat and Meat Products
16
In December 1999, the U.S. Department of Agriculture, Food Safety and Inspection
17
Service (USDA/FSIS) issued a final regulation to permit the use of ionizig radiation
18
to reduce foodborne pathogens, including Escherichia coli O157:H7, and extend
19
the shelf life of raw refrigerated and frozen meat and meat products (Irradiation of
20
Meat Food Products 64 Federal Register 72150, December 23, 1999).
21
The final regulations are published in Title 9 of the Code of Federal Regulations (9
22
CFR 424.21 Use of food ingredients and sources of radiation) and provide that raw
23
refrigerated products may receive a maximum absorbed dose of no more than 4.5
24
kGy, and that frozen products receive no more than 7.0 kGy, in accordance with
25
the FDA restrictions provided for in Title 21 of the Code of Federal Regulations (21
26
CFR 179.26(a) Ionizing radiation for the treatment of food, (a) Energy sources).
27
The regulations further require that all irradiated meat and meat products bear
28
labeling that reflects that the product was irradiated, or that the product contains an
29
irradiated meat or poultry product. This labeling requirement is applicable even at
30
retail facilities where irradiated coarse ground beef might be finely ground for retail
Guam Food Code Annex 1 – Public Health Reasons
79
the
FDA
website
1
sale, or in cases where irradiated product is combined with other non-irradiated
2
meat or poultry product for retail sale.
3
In cases where the entire package of product is irradiated, the labeling must include
4
both a statement and the international symbol, called the radura. Additionally, the
5
product name must include the word “irradiated,” or the labeling must bear a
6
disclosure statement such as, “treated with radiation” or “treated by irradiation.” If
7
either statement is used, the logo must be placed in conjunction with the statement.
8
If an irradiated meat or meat product is used to formulate a multi-ingredient product
9
with other non-irradiated components, the irradiated meat ingredient must be
10
identified as such in the ingredients statement, but the logo is not required. For
11
example, the ingredients statement for a Chicken and Beef Sausage product that
12
contains irradiated beef would be, Ingredients: chicken, irradiated beef, seasonings
13
(salt, pepper, spice), and the logo would not be required to be present.
14
All labels for products produced at federally inspected establishments bearing
15
statements about irradiation must be submitted to USDA/FSIS for evaluation and
16
approval prior to use.
17
Optional labeling statements about the purpose of the irradiation process may be
18
included on the labeling of irradiated products provided they are not false or
19
misleading and have been evaluated first by USDA/FSIS. If such statements
20
indicate a specific benefit from irradiation, such as a reduction of microbial
21
pathogens, such statements must be substantiated by processing documentation
22
and validated through the processing and Hazard Analysis and Critical Control
23
Point ( HACCP) system. Such validation and documentation of the HACCP system
24
would only be applicable in federally inspected establishments.
25
Because irradiation can substantially reduce and, in some situations, eliminate any
26
detectable level of pathogenic bacteria, it is important that the meat products be
27
held at the proper refrigerated temperatures to prevent growth of any pathogens
28
present, and that the packaging is not compromised.
29
irradiated beef with non-irradiated meat or poultry is not prohibited under the
30
current regulations, USDA/FSIS believes that such a process would decrease the
Although commingling
Guam Food Code Annex 1 – Public Health Reasons
80
1
benefit of irradiation by potentially exposing the irradiated product to pathogenic
2
bacteria. While FSIS considers such commingling to be highly unlikely, if it did
3
occur, a statement advising the consumer that the product contains both irradiated
4
and non-irradiated components would be required.
5
6
The Radura, International Symbol:
7
8
9
Further information about labeling irradiated raw meat is available through Directive
10
7700.1, Irradiation of Meat and Poultry Products, on the USDA/FSIS website at
11
http://www.fsis.usda.gov/oppde/rdad/fsisdirectives/7700-1.htm. Irradiation Questions &
12
Answers can be found at http://www.fsis.usda.gov/oppde/larc/policies/iradqa.pdf .
13
Labeling for Raw Shell Eggs
14
The Code of Federal Regulations 21 CFR 101.17 Food Labeling warning, notice,
15
and safe handling statements, paragraph (h) Shell eggs state in subparagraph
16
(1), “The label of all shell eggs, whether in intrastate or interstate commerce, shall
17
bear the following statement: „SAFE HANDLING INSTRUCTIONS: To prevent
18
illness from bacteria; keep eggs refrigerated, cook eggs until yolks are firm, and
19
cook foods containing eggs thoroughly.‟” Further, in subparagraph (4) it states,
20
“Shell eggs that have been, before distribution to consumers, specifically processed
21
to destroy all viable Salmonella shall be exempt from the requirements of paragraph
22
(h) of this section.”
23
Labeling for Whole-muscle, Intact Beef Steaks
24
In order for a food establishment operator to know that a steak is a whole-muscle,
25
intact cut of beef that
26
consumer advisory, the incoming product must be labeled.
can therefore be undercooked and served without a
Guam Food Code Annex 1 – Public Health Reasons
81
Processors can
1
accommodate this need at the retail level by developing proposed labels, obtaining
2
the necessary USDA Food Safety Inspection Service review and approval, and
3
appropriately affixing the labels to their products.
4
Refer also to public health reason for § 3-602.11.
3-201.12
5
Food in a Hermetically Sealed Container.*
6
Processing food at the proper high temperature for the appropriate time is essential
7
to kill bacterial spores that, under certain conditions in an airtight container, begin to
8
grow and produce toxin. Of special concern is the lethal toxin of Clostridium
9
botulinum, an organism whose spores (i.e., survival stages for non-growth
10
conditions) are found throughout the environment. Even slight underprocessing of
11
low acid food which is canned can be dangerous, because spoilage microbes are
12
killed and there are no signs to warn consumers that botulinum spores have
13
germinated into vegetative cells and produced their toxin. If these foods are not
14
processed to be commercially sterile, they must be received frozen or under proper
15
refrigeration.
16
Refer also to the public health reason for §§ 3-101.11 and 3-201.11.
17
3-201.13
Fluid Milk and Milk Products.*
18
Milk, which is a staple for infants and very young children with incomplete immunity
19
to infectious diseases, is susceptible to contamination with a variety of microbial
20
pathogens such as Shiga toxin-producing Escherichia coli, Salmonella spp., and
21
Listeria monocytogenes, and provides a rich medium for their growth. This is also
22
true of milk products.
23
contamination in milk and products derived from milk. Dairy products are normally
24
perishable and must be received under proper refrigeration conditions.
25
3-201.14
Pasteurization is required to eliminate pathogen
Fish.*
26
After December 18, 1997, all processors of fish are required by 21 CFR 123 to have
27
conducted a hazard analysis of their operation, identify each hazard that is
28
reasonably likely to occur, and implement a HACCP plan to control each identified
29
hazard. Retailers should assure that their seafood suppliers have complied with
30
this requirement. Hazards known to be associated with specific fish species are
Guam Food Code Annex 1 – Public Health Reasons
82
1
discussed in the FDA Fish and Fishery Products Hazards and Controls Guide,
2
available from the FDA Office of Seafood.
3
pathogens, parasites, natural toxins, histamine, chemicals, and drugs.
4
The seafood implicated in histamine poisoning are the scombroid toxin-forming
5
species, defined in 21 CFR 123.3(m) as meaning bluefish, mahi-mahi, tuna, and
6
other species, whether or not in the family Scombridae, in which significant levels
7
of histamine may be produced in the fish flesh by decarboxylation of free histidine
8
as a result of exposure of the fish after capture to temperatures that allow the
9
growth of mesophilic bacteria.
Species-related hazards include
10
Ciguatera toxin is carried to humans by contaminated fin fish from the extreme
11
southeastern U.S., Hawaii, and subtropical and tropical areas worldwide. In the
12
south Florida, Bahamian, and Caribbean regions, barracuda, amberjack, horse-eye
13
jack, black jack, other large species of jack, king mackerel, large groupers, and
14
snappers are particularly likely to contain ciguatoxin. Many other species of large
15
predatory fishes may be suspect. In Hawaii and throughout the central Pacific,
16
barracuda, amberjack, and snapper are frequently ciguatoxic, and many other
17
species both large and small are suspect. Mackerel and barracuda are frequently
18
ciguatoxic from mid to northeastern Australian waters.
19
RECREATIONALLY CAUGHT FISH
20
Recreationally caught fish received for sale or service may be approved by the
21
regulatory authority. The EPA recognizes that fish are a healthy part of our diet and
22
recognizes fishing as an all-American recreational pastime, however, they add the
23
cautionary note that some individuals, such as pregnant women and small children,
24
may need to limit their intake of certain noncommercial fish. Recreationally caught
25
fish may contain possible contaminants that may pose health risks. Fish advisories
26
can be found in EPA Listing of Fish Advisories the EPA website at:
27
http://www.epa.go/waterscience/fish.
28
States issue fish consumption advisories if elevated concentrations of chemicals
29
such as mercury or dioxin are found in local fish. For most people, the risk from
30
mercury by eating fish is not a health concern. Yet, some fish and shellfish contain
Guam Food Code Annex 1 – Public Health Reasons
83
1
higher levels of mercury that may harm an unborn baby or young child's developing
2
nervous system. Therefore, the FDA and the EPA recently advised women who
3
may become pregnant, pregnant women, nursing mothers, and young children to
4
avoid some types of fish and eat fish and shellfish that are lower in mercury.
5
(http://www.epa.gov/waterscience/fishadvice/advice.html).
6
State-issued advisories apply primarily to non-commercial fish obtained through
7
sport, recreation, and subsistence activities. Each advisory is different; it may
8
recommend unrestricted, limited, or totally restricted consumption; may be targeted
9
to everyone or limited to women, children, or other people at risk; and may apply to
10
certain species or sizes of fish or a specific waterbody.
11
States may issue safe-eating guidelines in addition to issuing fish advisories. A fish
12
advisory is issued to warn the public of the potential human health risks from
13
chemical contamination of certain species from particular types of waterbodies such
14
as lakes, rivers, and/or coastal waters within the State. In contrast, a safe-eating
15
guideline is issued to inform the public that fish from specific waterbodies have
16
been tested for chemical contaminants and the fish from these waters are safe to
17
eat without consumption restrictions.
18
Regulatory authorities are encouraged to monitor and review the National Listing of
19
Fish
20
http://www.epa.gov/waterscience/fish/advisories/factsheet.pdf as well as the local
21
listings, as part of the decision-making process regarding the approval of
22
recreationally caught fish being used in food establishments.
23
Advisories
(See
3-201.15
August
2004
EPA
Fact
Sheet
at
Molluscan Shellfish.*
24
Pathogens found in waters from which molluscan shellfish are harvested can cause
25
disease in consumers. Molluscan shellfish include: 1) oysters; 2) clams; 3)
26
mussels; and, 4) scallops, except where the final product is the shucked adductor
27
muscle only. The pathogens of concern include both bacteria and viruses.
28
Pathogens from the harvest area are of particular concern in molluscan shellfish
29
because: 1) environments in which molluscan shellfish grow are commonly subject
30
to contamination from sewage, which may contain pathogens, and to naturally
Guam Food Code Annex 1 – Public Health Reasons
84
1
occurring bacteria, which may also be pathogens; 2) molluscan shellfish filter and
2
concentrate pathogens that may be present in surrounding waters; and, 3)
3
molluscan shellfish are often consumed whole, either raw or partially cooked.
4
To minimize the risk of molluscan shellfish containing pathogens of sewage origin,
5
State and foreign government agencies, called Shellfish Control Authorities, classify
6
waters in which molluscan shellfish are found, based, in part, on an assessment of
7
water quality. As a result of these classifications, molluscan shellfish harvesting is
8
allowed from some waters, not from others, and only at certain times or under
9
certain restrictions from others. Shellfish Control Authorities then exercise control
10
over the molluscan shellfish harvesters to ensure that harvesting takes place only
11
when and where it has been allowed.
12
Significant elements of Shellfish Control Authorities' efforts to control the harvesting
13
of molluscan shellfish include:
14
molluscan shellfish (shellstock) bear a tag that identifies the type and quantity of
15
shellfish, harvester, harvest location, and date of harvest; and, 2) a requirement that
16
molluscan shellfish harvesters be licensed; 3) a requirement that processors that
17
shuck molluscan shellfish or ship, reship, or repack the shucked product be
18
certified; and, 4) a requirement that containers of shucked molluscan shellfish bear
19
a label with the name, address, and certification number of the shucker-packer or
20
repacker.
21
Pathogens, such as Vibrio vulnificus, Vibrio parahaemolyticus, Vibrio cholerae,
22
and Listeria monocytogenes that may be present in low numbers at the time that
23
molluscan shellfish are harvested, may increase to more hazardous levels if they
24
are exposed to time/temperature abuse. To minimize the risk of pathogen growth,
25
Shellfish Control Authorities place limits on the time between harvest and
26
refrigeration. The length of time is dependant upon either the month of the year or
27
the average monthly maximum air temperature (AMMAT) at the time of harvest,
28
which is determined by the Shellfish Control Authority.
29
Paralytic shellfish poisoning (PSP) results from shellfish feeding upon toxic
30
microorganisms such as dinoflagellates. In the U.S., PSP is generally associated
1) a requirement that containers of in-shell
Guam Food Code Annex 1 – Public Health Reasons
85
1
with the consumption of molluscan shellfish from the northeast and northwest
2
coastal regions of the U.S. PSP in other parts of the world has been associated with
3
molluscan shellfish from environments ranging from tropical to temperate waters. In
4
addition, in the U.S., PSP toxin has recently been reported from the viscera of
5
mackerel, lobster, dungeness crabs, tanner crabs, and red rock crabs.
6
Neurotoxic shellfish poisoning (NSP) in the U.S. is generally associated with the
7
consumption of molluscan shellfish harvested along the coast of the Gulf of Mexico,
8
and, sporadically, along the southern Atlantic coast. There has been a significant
9
occurrence of toxins similar to NSP in New Zealand, and some suggestions of
10
occurrence elsewhere.
11
For diarrhetic shellfish poisoning there has been no documented occurrence to date
12
in the U.S. However, instances have been documented in Japan, southeast Asia,
13
Scandinavia, western Europe, Chile, New Zealand, and eastern Canada.
14
Amnesic shellfish poisoning (ASP) is generally associated with the consumption of
15
molluscan shellfish from the northeast and northwest coasts of North America. It
16
has not yet been a problem in the Gulf of Mexico, although the algae that produce
17
the toxin have been found there. ASP toxin has recently been identified as a
18
problem in the viscera of dungeness crab, tanner crab, red rock crab, and
19
anchovies along the west coast of the United States.
20
Marine toxins are not ordinarily a problem in scallops if only the adductor muscle is
21
consumed. However, products such as roe-on scallops and whole scallops do
22
present a potential hazard for natural toxins.
23
To reduce the risk of illness associated with raw shellfish consumption, the Food
24
and Drug Administration (FDA) administers the National Shellfish Sanitation
25
Program (NSSP). The NSSP is a tripartite, cooperative action plan involving
26
Federal and State public health officials and the shellfish industry. Those groups
27
work together to improve shellfish safety. States regularly monitor waters to ensure
28
that they are safe before harvesting is permitted. FDA routinely audits the States'
29
classification of shellfish harvesting areas to verify that none pose a threat to public
30
health. Patrolling of closed shellfishing waters minimizes the threat of illegal
Guam Food Code Annex 1 – Public Health Reasons
86
1
harvesting or “bootlegging” from closed waters. Bootlegging is a criminal activity
2
and a major factor in shellfish-borne illnesses. Purchases from certified dealers
3
that adhere to NSSP controls is essential to keep risks to a minimum.
3-201.16
4
Wild Mushrooms.*
5
Over 5000 species of fleshy mushrooms grow naturally in North America. The vast
6
majority have never been tested for toxicity. It is known that about 15 species are
7
deadly and another 60 are toxic to humans whether they are consumed raw or
8
cooked. An additional 36 species are suspected of being poisonous, whether raw
9
or cooked. At least 40 other species are poisonous if eaten raw, but are safe after
10
proper cooking.
11
Some wild mushrooms that are extremely poisonous may be difficult to distinguish
12
from edible species. In most parts of the country there is at least one organization
13
that include individuals who can provide assistance with both identification and
14
program design. Governmental agencies, universities, and mycological societies
15
are examples of such groups.
16
mushrooms, management must recognize and address the need for a sound
17
identification program for providing safe wild mushrooms.
18
Regulatory authorities have expressed their difficulty in determining what
19
constitutes a “wild mushroom identification expert” and enforcing the Food Code
20
provisions associated with it. In 1998, the Conference for Food Protection (CFP)
21
attempted to alleviate this problem through the formation of a committee that was
22
charged with determining what constitutes a wild mushroom expert. However, the
23
committee was unable to provide this information in a practical, useful manner for
24
State and local regulators within the constraints of the Food Code. The 2000 CFP
25
recommended and FDA accepted the committee‟s alternative solution that a
26
brochure be developed that will provide information on what constitutes a wild
27
mushroom expert, and to replace “identification by a wild mushroom expert” with
28
“written buyer specifications.”
29
The CFP‟s recommendation attempts to provide the necessary information in a
30
practical, useful manner for all stakeholders, and yet still convey the highest level of
If a food establishment chooses to sell wild
Guam Food Code Annex 1 – Public Health Reasons
87
1
public health protection.
The CFP committee suggested that written buyer
2
specifications place more responsibility on the food establishment to ensure that
3
wild mushrooms are obtained from a safe source, and also provides State and local
4
regulators a template to use in ensuring wild mushrooms sold at retail are obtained
5
from a safe source.
6
However, the recommendation for written buyer specifications will not replace Food
7
Code paragraph 3-201.16(A) until the brochure is developed and accepted by the
8
CFP and FDA. In the interim, the following guidance is provided regarding the
9
identification of wild mushrooms:
10
A food establishment that sells or serves mushroom species picked in the wild shall
11
have a written buyer specification that requires identification of:
12
(1)
13
The Latin binomial name, the author of the name, and the common
name of the mushroom species,
14
(2)
That the mushroom was identified while in the fresh state,
15
(3)
The name of the person who identified the mushroom,
16
(4)
A statement as to the qualifications and training of the identifier,
17
specifically related to mushroom identification.
18
Additional information can be found on the California Poison Control website:
19
http://www.calpoison.org/public/mushrooms.html.
20
Refer also to the public health reason for §§ 3-101.11 and 3-201.11.
3-201.17
21
Game Animals.*
22
The primary concern regarding game animals relates to animals obtained in the
23
wild. Wild game animals may be available as a source of food only if a regulatory
24
inspection program is in place to ensure that wild animal products are safe. This is
25
important because wild animals may be carriers of viruses, rickettsiae, bacteria, or
26
parasites that cause illness (zoonoses) in humans. Some of these diseases can be
27
severe in the human host. In addition to the risk posed to consumers of game that
28
is not subject to an inspection program, there is risk to those who harvest and
29
prepare wild game because they may contract infectious diseases such as rabies or
30
tularemia.
Guam Food Code Annex 1 – Public Health Reasons
88
3-202.11
Temperature.*
1
Specifications
2
for Receiving
3
Temperature is one of the prime factors that controls the growth of bacteria in food.
4
Many, though not all, types of pathogens and spoilage bacteria are prevented from
5
multiplying to microbiologically significant levels in properly refrigerated foods that
6
are not out of date. USDA published a final rule (63 FR 45663, August 27, 1998
7
Shell Eggs; Refrigeration and Labeling Requirements) to require that shell eggs
8
packed for consumer use be stored and transported at an ambient temperature not
9
to exceed 7.2ºC (45ºF).
10
High temperatures for a long enough time, such as those associated with thorough
11
cooking, kill or inactivate many types of microorganisms. However, cooking does
12
not always destroy the toxins produced in foods by certain bacteria (such as the
13
enterotoxins of Staphylococcus aureus). Cooking or hot holding that follows
14
temperature abuse may not make the food safe. Keeping cooked foods hot as
15
required in the Code prevents significant regrowth of heat-injured microorganisms
16
and prevents recontamination with bacteria that are newly introduced.
3-202.12
17
Additives.*
18
It is imperative for safety that food supplies come from sources that are in
19
compliance with laws regarding chemical additives and contaminants.
20
Food additives are substances which, by their intended use, become components of
21
food, either directly or indirectly. They must be strictly regulated. In excessive
22
amounts or as a result of unapproved application, additives may be harmful to the
23
consumer. Unintentional contaminants or residues also find their way into the food
24
supply.
25
determined by risk assessment evaluations based on toxicity studies and
26
consumption estimates.
27
Food and Color additives must be used in compliance with a federal food, or color
28
additive regulation, an effective food-contact notification, or a threshold of
29
regulation exemption. Such regulations, notifications, and exemptions are generally
30
composed of three parts: the identity of the substance, specifications including
The tolerances or safe limits designated for these chemicals are
Guam Food Code Annex 1 – Public Health Reasons
89
1
purity or physical properties, and limitations on the conditions of use. In order for a
2
food, or color additive use to be in compliance, the use must comply with all three
3
criteria.
4
Federal Food Additive regulations are found in Title 21 CFR, Parts 172-180. Color
5
additive regulations are found in Title 21 CFR Parts 73-Subpart A, 74-Subpart A, 81
6
and
7
http://vm.cfsan.fda.gov/~dms/opa-fcn.html, and threshold of regulation exemptions
8
are listed at http://www.cfsan.fda.gov/~dms/opa-torx.html.
9
Other substances that are added to food include those prior sanctioned for use in
10
food by either the FDA or USDA, or those generally recognized as safe for their
11
intended use in food. Some of these are listed in Title 21 CFR Parts 181-186, Title
12
9 CFR Section 424.21(b) and at http://www.cfsan.fda.gov/~rdb/opa-gras.html.
13
Tolerances and exemptions from tolerance for pesticide chemical residues in or on
14
food are found in Title 40 CFR Part 180. Substances that are prohibited from use in
15
human food are listed in Title 21 CFR Part 189.
82.
Effective
food-contact
3-202.13
16
notifications
are
listed
at
Eggs.*
17
Damaged shells permit the entry of surface bacteria to the inside of eggs. Eggs are
18
an especially good growth medium for many types of bacteria. Damaged eggs must
19
not be used as food.
20
The Definition of “Restricted Egg” contains several terms that are explained in this
21
paragraph. An egg may be restricted because it is a/an:
22
(i)
23
24
but has its shell membranes intact and contents not leaking.
(ii)
25
26
“Check” meaning an egg that has a broken shell or crack in the shell
“Dirty egg or Dirties” meaning an egg that has a shell that is unbroken
and has adhering dirt, foreign material, or prominent stains.
(iii)
“Incubator reject” meaning an egg that has been subjected to
27
incubation and has been removed from incubation during the
28
hatching operations as infertile or otherwise unhatchable.
29
30
(iv)
“Inedible” meaning eggs of the following descriptions: Black rots,
yellow rots, white rots, mixed rots, sour eggs, eggs with green whites,
Guam Food Code Annex 1 – Public Health Reasons
90
1
eggs with stuck yolks, moldy eggs, musty eggs, eggs showing blood
2
rings, and eggs containing embryo chicks (at or beyond the blood ring
3
stage).
4
(v)
“Leaker” meaning an egg that has a crack or break in the shell and
5
shell membranes to the extent that the egg contents are exposed or
6
are exuding or free to exude through the shell.
7
(vi)
“Loss” meaning an egg that is unfit for human food because it is
8
smashed or broken so that its contents are leaking; or overheated,
9
frozen, or contaminated; or an incubator reject; or because it contains
10
a bloody white, large meat spots, a large quantity of blood, or other
11
foreign material.
12
On December 5, 2000, Federal regulations were amended to require that shell egg
13
cartons bear safe handling instructions and be placed under refrigeration at 45°F or
14
lower upon delivery at retail establishments (65 FR 76091, December 5, 2000, Food
15
Labeling, Safe Handling Statements, Labeling of Shell Eggs; Refrigeration of Shell
16
Eggs Held for Retail Distribution). The amended provisions include:
17
21 CFR Part 16 Regulatory Hearing before the Food and Drug
18
Administration, § 16.5 Inapplicability and limited applicability, (4) A
19
hearing on an order for re-labeling, diversion or destruction of shell
20
eggs…
21
21 CFR Part 101 Food Labeling §101.17 Food labeling warning,
22
notice, and safe handling statements, (h) Shell eggs.
23
21 CFR Part 115 Shell Eggs, § 115.50. Refrigeration of shell eggs
24
held for retail distribution.
25
The labeling rule became effective September 4, 2001, and the refrigeration rule
26
became effective June 4, 2001. These rules are one part of a larger farm-to-table
27
approach for ensuring the safety of our nation‟s egg supply. The public health goal
28
is a 50 percent reduction in all salmonellosis and a 50 percent reduction in
29
Salmonellae Enteritidis illnesses by 2010.
30
3-202.14
Eggs and Milk Products, Pasteurized.*
Guam Food Code Annex 1 – Public Health Reasons
91
1
Liquid egg, fluid milk, and milk products are especially good growth media for many
2
types of bacteria and must be pasteurized. Pasteurization is a heat process that
3
will kill or inactivate bacteria and other harmful microorganisms likely to be in these
4
potentially hazardous foods (time/temperature control for safety foods). Freezing
5
and drying of unpasteurized products will stop microbial growth and may reduce
6
their bacterial populations; however, some organisms will survive because neither
7
process invariably kills bacteria. Under certain conditions, freezing and drying may
8
preserve microbes. An alternative to pasteurization may be applicable to certain
9
cheese varieties cured or aged for a specified amount of time prior to marketing for
10
consumption.
3-202.15
11
Package Integrity.*
12
Damaged or incorrectly applied packaging may allow the entry of bacteria or other
13
contaminants into the contained food. If the integrity of the packaging has been
14
compromised, contaminants such as Clostridium botulinum may find their way
15
into the food. In anaerobic conditions (lack of oxygen), botulism toxin may be
16
formed.
17
Packaging defects may not be readily apparent. This is particularly the case with
18
low acid canned foods. Close inspection of cans for imperfections or damage may
19
reveal punctures or seam defects. In many cases, suspect packaging may have to
20
be inspected by trained persons using magnifying equipment. Irreversible and even
21
reversible swelling of cans (hard swells and flippers) may indicate can damage or
22
imperfections (lack of an airtight, i.e., hermetic seal). Swollen cans may also
23
indicate that not enough heat was applied during processing (underprocessing).
24
Suspect cans must be returned and not offered for sale.
25
3-202.16
26
Freezing does not invariably kill microorganisms; on the contrary, it may
27
preserve them. Therefore, ice that comes into contact with food to cool it or that is
28
used directly for consumption must be as safe as drinking water that is periodically
29
tested and approved for consumption.
30
3-202.17
Ice.*
Shucked Shellfish, Packaging and Identification.
Guam Food Code Annex 1 – Public Health Reasons
92
1
Plastic containers commonly used throughout the shellfish industry for shucked
2
product bear specific information regarding the source of the shellfish as required
3
by the NSSP Guide for the Control of Molluscan Shellfish. These containers must
4
be nonreturnable so that there is no potential for their subsequent reuse by shellfish
5
packers
6
identified by the label.
7
establishment must be assessed on the basis of the Food Code's criteria
8
for
9
relabeled to reflect their new contents.
which
multi-use
could result
in
shucked
product that
is inaccurately
The reuse of these containers within the food
containers and the likelihood that they will be properly
3-202.18
10
Shellstock Identification.*
11
Accurate source identification of the harvesting area, harvester, and dealers
12
must be contained on molluscan shellstock identification tags so that if a
13
shellfish-borne
14
expedite the epidemiological investigation and regulatory action.
disease outbreak occurs, the information is available to
3-202.19
15
Shellstock, Condition.
16
Dirty, damaged, or dead shellstock can contaminate and degrade live and
17
healthy
18
primary responsibility for culling shellstock, but this responsibility continues
19
throughout the distribution chain.
shellstock
and lead to foodborne illness. Harvesters have the
3-202.110
20
Juice Treated.
21
Refer to public health reason for § 3-801.11.
22
Original
23
Containers and
24
Records
25
Lot separation is critical to isolating shellfish implicated in illness outbreaks
26
and tracking them to their source. Proper identification is needed for tracing
27
the origin and determining conditions of shellfish processing and shipment. If
28
the lots are commingled at retail, traceability is undermined and the root of
29
the problem may remain undetected. If no causative factors are identified
30
in the food establishment, tracing the incriminated lot helps in identifying
3-203.11
Molluscan Shellfish, Original Container.
Guam Food Code Annex 1 – Public Health Reasons
93
1
products that need to be recalled or growing waters that may need to be
2
closed to harvesting.
3
When
4
containers, the labeling information as specified under section 3-202.17 must
5
be recorded on a log sheet to correlate with the date of sale of the
6
consumer sized containers.
shucked
shellfish
3-203.12
7
are
prepackaged
in
consumer
self
service
Shellstock, Maintaining Identification.*
8
Accurate records that are maintained in a manner that allows them to be
9
readily matched to each lot of shellstock provide the principal mechanism for
10
tracing shellstock to its original source.
If an outbreak occurs, regulatory
11
authorities must move quickly to close affected growing areas or take other
12
appropriate actions to prevent further illnesses.
13
90 days to allow time for hepatitis A virus infections, which have an
14
incubation period that is significantly longer than other shellfish-borne
15
diseases, to
16
following considerations:
Records must be kept for
come to light. The 90 day requirement is based on the
17
Shelf-life of the product ................................... 14 days
18
Incubation period .............................................. 56 days
19
Medical diagnosis and confirmation .................. 5 days
20
Reporting .......................................................... 5 days
21
Epidemiological investigation ........................... 10 days
22
Total .................................................................. 90 days
23
In reality and as stated in the provision, the 90-day “clock” starts at the
24
time
25
harvest is not correct because the shellstock may be sold/consumed in less
26
than the 14 days of shelf life cited in the chart above. Therefore, the 90
27
days may expire and the tag discarded before an illness is reported and
28
investigated.
29
Shellstock
30
estimated
the container of shellstock is emptied.
could
Starting from the date of
be frozen in the food establishment during the 14-day
shelf life period, which would effectively stop the clock on the
Guam Food Code Annex 1 – Public Health Reasons
94
1
shelf life. The shellstock could be thawed and consumed past the 14-day
2
shelf life. In this case, the 90 days would expire before consumption if the
3
clock started 90 days from the harvest date.
4
Freezing shellstock in the food establishment is not usually done because,
5
although
6
have the same texture and appearance of a fresh oyster when thawed.
7
Commercially frozen oysters are frozen rapidly to retain product quality.
8
Preventing
9
Contamination
10
by Employees
11
In
12
Criteria for Foods (NACMCF) concluded that bare hand contact with ready-
13
to-eat foods can contribute to the transmission of foodborne illness and
14
agreed
15
recommended exclusion/restriction of ill food workers as the first preventative
16
strategy and recognized that this intervention has limitations, such as trying
17
to identify and manage asymptomatic food workers.
18
The
19
transmitted through the fecal-oral route, identified by the NACMCF, include
20
exclusion/restriction of ill food workers; proper handwashing; and no bare
21
hand contact with ready-to-eat foods. Each of these factors is inadequate
22
when utilized independently and may not be effective. However, when all
23
three factors are combined and utilized properly, the transmission of fecal-
24
oral pathogens can be controlled. Depending on the microbial contamination
25
level on the hands, handwashing with plain soap and water, as specified
26
in the Food Code, may not be an adequate intervention to prevent
27
transmission of pathogenic microbes to ready-to-eat foods via hand contact
28
with ready-to-eat foods.
29
reduce microbial contamination of the hands by 2-3 logs.
oysters-in-the-shell can be frozen with fair results, they do not
3-301.11
Preventing Contamination from Hands.*
November 1999, the National Advisory Committee for Microbiological
that
three
the
transmission
interdependent
critical
could
be interrupted.
The NACMCF
factors in reducing foodborne illness
the
Handwashing as specified in the Food Code will
Guam Food Code Annex 1 – Public Health Reasons
95
1
Food
employees
2
pathogens can shed viral and protozoan pathogens in the feces at levels up
3
to 108 viral particles or oocysts per gram of feces. Having a high potential
4
contamination level on the hands combined with a very low infectious dose
5
necessary
6
handwashing alone is not an effective single barrier in the transmission
7
of
8
Cryptosporidium is believed to be as low as 1-10 oocysts, and as few as
9
10 virus particles can infect an individual with Norovirus or hepatitis A.
to
and
cause
conditional
infection
employees
infected
are the reasons that
with
fecal-oral
FDA believes that
these fecal-oral pathogens. The infective dose for
Giardia and
10
The CDC now estimates that Norovirus is the leading cause of foodborne
11
illness in the United States. Contaminated hands are a significant factor
12
in the transmission of enteric viruses, including Norovirus and hepatitis A
13
virus.
14
most common mode of transmission of hepatitis A in foodborne disease
15
outbreaks. Research has shown the viral transfer rate from contaminated
16
hands to ready-to-eat food to be about 10% and that proper handwashing
17
will significantly reduce the chance of transmitting pathogenic viruses.
18
However, with heavy initial contamination of the hands, especially in the
19
subungal space
20
procedure may not be adequate to prevent the transmission of viral
21
foodborne illness.
22
Even though bare hands should never contact exposed,
23
thorough handwashing is important in keeping gloves or other utensils from
24
becoming vehicles for transferring microbes to the food.
25
Refer to the public health reasons for §§ 2-301.11, 2-301.12, and 2-301.14.
26
3-301.11(D) Prior Approval for Food Employees to
27
Touch Ready-to-Eat Food with Bare Hands
28
Infected food employees are the source of contamination in approximately
29
one in five foodborne disease outbreaks reported in the United States with
Further, contamination
of food by an infected food worker is the
of the fingers, a basic 2-3 log reduction handwash
Guam Food Code Annex 1 – Public Health Reasons
96
ready-to-eat food,
1
a bacterial or viral cause.1
2
fecal-oral agents.
3
their stools at the time the food was prepared.
4
nonexistent handwashing procedures, workers spread these organisms to
5
the food. In addition, infected cuts,
6
result in contamination of food. Viral, bacterial, and parasitic agents can
7
be involved.
8
Traditionally, food regulations have required two methods of preventing the
9
spread of foodborne disease by this mode of transfer, i.e., they have
10
prohibited food workers from preparing food when they are infectious and
11
have required thorough and frequent handwashing. In order to strengthen
12
fecal-oral transmission interventions, the Food Code provides focused and
13
specific guidance about ill workers and when handwashing must occur. As
14
a final barrier, bare-hand contact with ready-to-eat food (i.e., food that is
15
edible without washing or is not subsequently subjected to a pathogen kill
16
step) is prohibited and suitable utensils such as spatulas, tongs, single-use
17
gloves, or dispensing equipment are required to be used. Any alternative to
18
this requirement must convincingly address how food employees will be
19
managed to preclude food contamination and how management will ensure
20
that thorough handwashing occurs after employees use the toilet.
21
Because highly susceptible populations include persons who are
22
immunocompromised, the very young and elderly, establishments serving
23
these populations may not use alternatives to the no bare hand contact
24
with ready-to-eat food requirement.
25
Acceptability of an alternative procedure to no bare hand contact requires
26
prior approval from the regulatory authority based on the food establishment
27
having
Most of these outbreaks involve enteric, i.e.,
These are organisms that employees were shedding in
Because of poor or
burns, or boils on hands can also
a written employee health policy that details how the establishment
1
Based on CDC Summary Surveillance for Foodborne-Disease Outbreaks – United States, 1988-1992 and New York
State Department of Health data 1980-1991 published: Weingold, Guzewich, Fudala, 1994, Use of Foodborne Disease
Data for HACCP Risk Assessment. J. Food Prot. 53: 820-830.
Guam Food Code Annex 1 – Public Health Reasons
97
1
complies with management of ill employees as specified under sections 2-
2
201.11 - .13 and management of handwashing practices as specified under
3
Part 2-3 of the Code. The approval should also be based on evidence
4
provided through written procedures and documentation that at least all of
5
the following are addressed:
6
(A) Personal Cleanliness, i.e., handwashing procedures, including
7
frequency and methodology of handwashing that ensure food employees keep
8
their hands and fingertips clean and handwashing occurs at the times
9
specified in section 2-301.14, including after using the toilet and between tasks
10
that may recontaminate the hands.
11
(B) Hygienic Practices as specified in Part 2-4.
12
(C) Employee Health regarding:
13
(1) Reporting of diseases and medical conditions, and
14
(2) Exclusions and restrictions, i.e., that food employees and
15
conditional
16
section 2-201.11; ill food employees are restricted
17
specified in section 2-201.12; and the exclusions and restrictions are
18
removed as specified in section 2-201.13;
employees report their health status as specified in
or excluded as
19
(D) How the alternative practices and procedures will control the hazard
20
through an active managerial control program.
21
includes monitoring
22
described in paragraphs A-C above and satisfies the following:
Such a program
and verifying the institution of the provisions
23
(1) The public health hazard associated with bare hand contact
24
specific to the food establishment operation is identified and understood.
25
The regulatory authority needs assurance that the
26
recognizes
27
contamination of ready-to-eat food by viral and parasitic as well as
28
bacterial pathogens that are transferred from employees‟ hands.
29
(2) The ready-to-eat foods that will be contacted with bare hands are
30
identified and both procedures and practices are in place so that
that
the hazard
being
addressed
Guam Food Code Annex 1 – Public Health Reasons
98
permit
is
the
holder
possible
1
food employees wash their hands before returning to their work station
2
and cross-contamination from touching raw and ready-to-eat food is
3
precluded.
4
For example, identifying the specific type of food to be prepared,
5
such as tacos, and the specific location, such as a situation where a
6
food employee is assigned solely to the designated taco work
7
station. The work station is located immediately adjacent to the taco
8
assembly unit and the employee will be preparing only the specified
9
ready-to-eat food using bare hands.
10
Another example could be a food employee who is responsible solely for
11
assembling a variety of ready-to-eat foods.
12
(3) Institution of an effective training program for food employees that
13
emphasizes not working when ill with any of the gastrointestinal
14
symptoms listed in the Code, and explains good hygienic practices,
15
proper handwashing procedures,
16
procedures.
17
specifies
18
designated,
19
administration including periodic refresher sessions.
and
safe
food
preparation
This should include a documented training plan that
how
management
training
program
clearly
frequency
describe
of
21
documentation, and verification actions to ensure that the practices and
22
procedures are followed. Corrective actions need to be predetermined for
23
situations where the practices and procedures are not followed, e.g., an
24
ill employee is found preparing foods.
25
(F) Documentation of the practices, procedures, and corrective actions
26
related to an alternative to no bare hand contact with ready-to-eat food
27
must be maintained and readily available at the food establishment at all
28
times for use by the person in charge and for review by the regulatory
29
authority.
3-302.11
should
the
(E) The
Preventing
procedure
content, and
been
20
30
alternative
responsibility for training has
monitoring,
Packaged and Unpackaged Food – Protection
Guam Food Code Annex 1 – Public Health Reasons
99
Separation, Packaging, and Segregation.*
1
Food and
2
Ingredient Contamination
3
With
4
subparagraph 3-302.11(A)(2), it is the intent of this Code to require
5
separation
6
(species). Raw animal foods shall be separated based on a succession of
7
cooking temperatures since cooking temperatures as specified under § 3-
8
401.11 are based on
9
load. For example, to prevent cross-contamination, fish and pork, which are
10
required to be cooked to an internal temperature of 145°F for 15 seconds,
11
shall be stored above or away from raw poultry, which is required to be
12
cooked
13
considerably higher anticipated microbial load. In addition, raw animal foods
14
having the same cooking temperature, such as pork and fish, shall be
15
separated from one another during storage and preparation by maintaining
16
adequate spacing or by placing the food in separate containers because of
17
the potential for allergen cross-contamination or economic adulteration via
18
inadvertent species substitution.
19
Food that is inadequately packaged
20
could become contaminated by microbes, dust, or chemicals introduced by
21
products
or equipment stored in close proximity or by persons delivering,
22
stocking,
or opening packages
23
appropriate for
24
such as chemicals.
25
containers and may contaminate food if the packaging is inadequate or
26
damaged, or when the packaging is opened. The removal of food product
27
overwraps may also damage the package integrity of
28
overwraps if proper care is not taken.
29
30
regard
to
based
the
storage
of
raw animal foods as specified under
on anticipated microbial load and raw animal food type
thermal
destruction data and anticipated microbial
to an internal temperature of 165°F
for
15
seconds
due to its
or contained in damaged packaging
or
overwraps.
Packaging must be
preventing the entry of microbes and other contaminants
3-302.12
These contaminants may be present on the outside of
foods under the
Food Storage Containers, Identified with Common
Name of Food.
Guam Food Code Annex 1 – Public Health Reasons
100
1
Certain foods may be difficult to identify after they are removed from their
2
original
3
ingredients.
4
The
5
requested that it not be used, may result in severe medical consequences.
6
The mistaken use of food from unlabeled containers could result in chemical
7
poisoning. For example, foodborne illness and death have resulted from the
8
use of unlabeled salt, instead of sugar, in infant formula and special dietary
9
foods. Liquid foods, such as oils, and granular foods that may resemble
10
packaging.
Consumers
may be allergic to certain foods or
mistaken use of an ingredient, when the consumer has specifically
cleaning compounds are also of particular concern.
3-302.13
11
Pasteurized Eggs, Substitute for Raw Shell Eggs for
Certain Recipes.*
12
13
Raw or undercooked eggs that are used in certain dressings or sauces are
14
particularly
15
may
16
product that is free of pathogens and is a ready-to-eat food.
17
pasteurized product should be substituted in a recipe that requires raw or
18
undercooked eggs.
19
3-302.14
hazardous because the virulent organism Salmonella Enteritidis
be present in raw
shell eggs.
Pasteurized eggs provide an egg
The
Protection from Unapproved Additives.*
20
Refer to the public health reason for § 3-202.12.
21
Use of unapproved additives, or the use of approved additives in amounts
22
exceeding those allowed by food additive regulations could result in
23
foodborne illness, including allergic reactions.
24
reactions have occurred because of the indiscriminate use of sulfites to
25
retard “browning” of fruits and vegetables or to cause ground meat to look
26
“redder” or fresher.
27
The concern for misuse of additives also applies to food establishments
28
operating under a variance and to Annex
29
Model Food Code which addresses the use of sodium nitrite or other curing
30
agents in smoking and curing operations. However, if this process is done
For example, many adverse
6 Food Processing Criteria of
Guam Food Code Annex 1 – Public Health Reasons
101
1
incorrectly, it could cause illness or death because of excessive nitrite or
2
because the food is insufficiently preserved.
3-302.15
3
Washing Fruits and Vegetables.
4
Pathogenic organisms and chemicals may be present on the exterior
5
surfaces of raw fruits and vegetables. Washing removes the majority of
6
organisms and/or chemicals present. If nondrinking water is used, the fruits and
7
vegetables could become contaminated.
8
Toxic or undesirable residues could be present in or on the food if
9
chemicals used
for
washing
purposes are unapproved or applied in
10
excessive concentrations.
11
On October 26, 1998, a voluntary guidance document which addresses
12
practices commonly used by fresh fruit and vegetable producers was issued
13
jointly
14
information related to washing fruits and vegetables as well as the
15
application of antimicrobial agents.
16
Safety Hazards for Fresh Fruits and Vegetables” is available from FDA‟s
17
Food
18
http://www.fda.gov/dms/prodguid.html.
19
Preventing
20
Contamination
21
from Ice Used
22
as a Coolant
23
Ice that has been in contact with unsanitized surfaces or raw animal foods
24
may contain pathogens and other contaminants. For example, ice used to
25
store or display fish or packaged foods could become contaminated with
26
microbes present on the fish or packaging. If this ice is then used as a food
27
ingredient, it could contaminate the final product.
by FDA, USDA, and CDC.
Safety Initiative
3-303.11
staff
This voluntary guidance contains useful
The “Guide to Minimize Microbial Food
and
also
on
the
Internet
at
Ice Used as Exterior Coolant, Prohibited as
Ingredient.
Guam Food Code Annex 1 – Public Health Reasons
102
1
3-303.12
Storage or Display of Food in Contact with Ice and Water.
2
Packages that are not watertight may allow entry of water that has been
3
exposed to unsanitary exterior surfaces of packaging, causing the food to be
4
contaminated. This may also result in the addition of water to the food that
5
is unclaimed in the food's formulation and label.
6
Unpackaged foods such as fresh fish are often stored and/or displayed on
7
ice.
8
because,
9
water
A
potential for increasing the microbial load of
a
food
exists
as the ice melts, pathogens from one food may be carried by
to other foods.
The potential
for contamination is reduced by
10
continuous draining of melting ice.
11
Preventing
12
Contamination
13
From Equipment,
14
Utensils, and
15
Linens
16
Pathogens can be transferred to food from utensils that have been stored
17
on surfaces which have not been cleaned and sanitized. They may also be
18
passed on by consumers or employees directly, or indirectly from used
19
tableware or food containers.
20
Some
21
periods of time.
22
surfaces that are not clean and sanitized is liable to such contamination.
23
The handles of utensils, even if manipulated with gloved hands, are
24
particularly susceptible to contamination.
25
Probe-type price or identification tags are defined as a utensil. This means
26
that
27
Parts 4-1 Materials for Construction and Repair, and 4-2 Design and
28
Construction. Probe-type price or product identification tags can cause
29
microbial, chemical, or
30
constructed, and maintained.
3-304.11 Food Contact with Equipment and Utensils.*
pathogenic microorganisms survive outside the body for considerable
if such tags
Food that comes into contact directly or indirectly with
are for multiuse, they must meet the criteria listed in
physical
contamination if
not
Guam Food Code Annex 1 – Public Health Reasons
103
properly
designed,
1
The Food Code defines gloves as a “utensil” and therefore gloves must
2
meet the applicable requirements related to utensil construction, cleaning, and
3
storage.
3-304.12
4
In-Use Utensils, Between-Use Storage.
5
Refer to the public health reason for § 3-304.11.
6
Once a food employee begins to use a utensil such as a ladle, spatula, or
7
knife, that has been previously cleaned and sanitized, it is then considered
8
an in-use utensil. In-use utensils, used on a continuous or intermittent basis
9
during preparation or dispensing, must be cleaned and sanitized
on a
10
schedule that precludes the growth of pathogens that may have been
11
introduced onto utensil surfaces.
12
water maintained at 135oF or above during intermittent use because microbial
13
growth is controlled at such temperatures.
14
A food utensil should be designed and used to prevent bare hand contact
15
with ready-to-eat food or to minimize contact with food that is not in a ready-
16
to-eat
17
improperly designed for the task or whether a food employee is misusing an
18
appropriately designed utensil.
form.
On-site evaluations can be made to determine if a utensil is
3-304.13
19
In-use utensils may be safely stored in hot
Linens and Napkins, Use Limitation.
20
Because of their absorbency, linens and napkins used as liners that contact
21
food must be replaced whenever the container is refilled. Failure to replace
22
such liners could cause the linens or napkins to become fomites.
3-304.14
23
Wiping Cloths, Use Limitation.
24
Soiled wiping cloths, especially when moist, can become breeding grounds for
25
pathogens that could be transferred to food. Any wiping cloths that are not
26
dry (except those used once and then laundered) must be stored in a
27
sanitizer solution at all times, with the proper sanitizer concentration in the
28
solution.
29
effectiveness of, and neutralize, the sanitizer. The sanitizing solution must be
30
changed as needed to minimize the accumulation of organic material and
Wiping cloths soiled
with
organic
material can overcome
Guam Food Code Annex 1 – Public Health Reasons
104
the
1
sustain proper concentration.
Proper sanitizer concentration should be
2
ensured by checking the solution periodically with an appropriate chemical
3
test kit.
4
3-304.15
Gloves, Use Limitation.
5
Refer to the public health reason for § 3-304.11.
6
Gloves used in touching ready-to-eat food are defined as a “utensil” and
7
must meet the applicable requirements related to utensil construction, good
8
repair, cleaning, and storage.
9
Multiuse gloves, especially when used
repeatedly and soiled, can become
10
breeding grounds for pathogens that could be transferred to food.
11
gloves can directly contaminate food if stored with ready-to-eat food or may
12
indirectly contaminate food if stored with articles that will be used in contact
13
with food.
14
activities that contaminate the gloves. Hands must be washed before donning
15
gloves. Gloves must be discarded when soil or other contaminants enter the
16
inside of the glove.
17
Slash-resistant gloves are not easily cleaned and sanitized. Their use with
18
ready-to-eat foods could contaminate the food.
19
Natural Rubber Latex (NRL) Gloves
20
Natural rubber latex gloves have been reported to cause allergic reactions in
21
some individuals who wear latex gloves during food preparation, and even in
22
individuals eating food prepared by food employees wearing latex gloves
23
(refer to Annex 2, 3-304.15 of the 2005 Model Food Code). This information
24
should be taken into consideration when deciding whether single-use gloves
25
made of latex will be used during food preparation.
26
Although many allergic reactions occur as a result of occupational exposure,
27
CFSAN is actively reviewing its current policy on the use of disposable NRL
28
gloves in food operations in light of the possible transmission of the latex
29
protein via food. To
30
allegedly due to the ingestion of food contaminated by NRL in retail settings,
Multiuse gloves must be washed, rinsed, and
Soiled
sanitized between
gain additional information regarding allergic reactions
Guam Food Code Annex 1 – Public Health Reasons
105
1
CFSAN has been collecting reports of such reactions from consumers who have
2
contacted
3
collaborate in reviewing incoming data. The results of these activities and
4
other related efforts will be used to determine if policy changes regarding
5
the use of latex in food operations, based on food safety considerations, are
6
warranted.
7
The FDA, Office of Food Additive Safety, Division of Food Contact
8
Notification, reviews gloves submitted for food-contact use in the food
9
industry on the basis of the glove‟s formulation or components.
the Agency.
Several
offices
within
CFSAN will continue to
FDA
10
regulates NRL gloves used for medical purposes only.
11
FDA is aware of the following information related to occupational hazards (
12
not food safety hazards) associated with the use of NRL gloves:
13
The National Institute for Occupational Safety and Health (NIOSH) published
14
a 1997 Alert titled “Preventing Allergic Reactions to Natural Rubber Latex in
15
the Workplace” (NIOSH publication number 97-135) which is found at
16
http://www.cdc.gov/niosh/latexalt.html.
17
The American College of Allergy, Asthma and Immunology (ACAAI) and
18
the American Academy of Allergy Asthma and Immunology (AAAAI) issued a
19
joint statement discouraging the routine use of NRL gloves by food handlers.
20
(1997) http://www.acaal.org/public/physicians/joint.htm.
21
The AAAAI provides information on latex allergies on the web at
22
http://www.aaaai.org/patients/resources/fastfacts/latex_allergy.stm .
23
The ACAAI provides information on latex allergies on the web at
24
http://www.acaai.org/public/facts/latex.htm.
25
An OSHA Technical Information Bulletin recommends reducing allergy
26
potential by reducing unnecessary exposure to NRL. Stating “Food service
27
workers ... do not need to use NRL gloves for food handling...” (1999)
28
http://www.osha.gov/dts/tib/tib_data/tib19990412.html .
29
OSHA addresses gloves in the following Federal regulation, which can
30
be found at:
Guam Food Code Annex 1 – Public Health Reasons
106
1
http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=STANDAR
2
DS&p_id=9788.
3
OSHA Regulations (Standards - 29 CFR)
4
Standard Number: 1910.138
5
Standard Title: Hand Protection.
6
SubPart Number: I
7
SubPart Title: Personal Protective Equipment
8
(a) General requirements. Employers shall select and require employees to
9
use appropriate hand protection when employees' hands are exposed to hazards
10
such as those from skin absorption of harmful substances; severe cuts or
11
lacerations; severe abrasions; punctures; chemical burns; thermal burns; and
12
harmful temperature extremes.
13
(b) Selection. Employers shall base the selection of the appropriate hand
14
protection on an evaluation of the performance
15
protection relative to the task(s) to be performed, conditions present, duration
16
of use, and the hazards and potential hazards identified.
3-304.16
17
characteristics of the hand
Using Clean Tableware for Second
Portions and Refills.
18
19
Refer to the public health reason for § 3-304.11.
20
3-304.17
Refilling Returnables.
21
Refer to the public health reason for § 3-304.11.
22
Preventing
3-305.11
Food Storage.
23
Contamination
3-305.12
Food Storage, Prohibited Areas.
24
from the
25
Premises
26
Pathogens can contaminate and/or grow in food that is not stored properly.
27
Drips of condensate and drafts of unfiltered air can be sources of microbial
28
contamination for stored food. Shoes carry contamination onto the floors of
29
food preparation and storage areas. Even trace amounts of refuse or wastes
30
in rooms used as toilets or for dressing, storing garbage or implements, or
Guam Food Code Annex 1 – Public Health Reasons
107
1
housing
machinery
2
conditions in storage areas promote microbial growth.
3-305.13
3
can
become
sources of food contamination.
Moist
Vended Potentially Hazardous Food (Time/Temperature
Control for Safety Food), Original Container.
4
5
The possibility of product
contamination increases whenever
food is
6
exposed. Changing the container(s) for machine vended potentially hazardous
7
food (time/temperature control for safety food) allows microbes that may be
8
present an opportunity to contaminate the food. Pathogens could be present
9
on the hands of the individual packaging the food, the equipment used, or
10
the exterior of the original packaging.
11
hazardous foods (time/temperature control for safety foods) are vended in a
12
hermetically sealed state to ensure product safety. Once the original seal is
13
broken, the food is vulnerable to contamination.
3-305.14
14
In addition, many potentially
Food Preparation.
15
Food preparation activities may expose food to an environment that may
16
lead to the food's contamination.
17
storage,
18
environmental contamination
may include splash from cleaning operations,
19
drips
conditioning vents, or air from an uncontrolled
20
atmosphere such as may be encountered when preparing food in a building
21
that is not constructed according to Food Code requirements.
22
Preventing
23
Contamination
24
by Consumers
25
During display, food can be contaminated even when there is no direct hand
26
contact.
27
currents through fine sprays or aerosols.
28
breathing or sneezing, water sprays directed at drains, or condensate from air
29
conditioners. Even wind gusts across sewage deposits and fertilized fields
it
form
must
Just as food must be protected during
also be protected
overhead
air
3-306.11
during
preparation.
Sources
of
Food Display.
Many microbes can be conveyed considerable distances on air
These may originate from people
Guam Food Code Annex 1 – Public Health Reasons
108
1
have been known to contaminate food in adjacent establishments where food
2
was unprotected.
3-306.12
3
Condiments, Protection.
4
Unpackaged condiments are exposed to contamination by consumers who
5
could
6
condiments are contaminated, subsequent consumers using the condiments may
7
be exposed to pathogens. Condiments in individual packages are protected
8
from consumer contamination.
9
On- or off-site facilities for refilling condiment dispensers must be adequately
10
equipped to ensure that the filling operation does not introduce contaminants.
be suffering from a disease transmissible through food. Once the
3-306.13
11
Consumer Self-Service Operations.*
12
Raw foods of animal origin usually contain pathogens. In addition, these
13
foods, if offered for consumer self-service, could cross contaminate other
14
foods stored in the same display. Because raw foods of animal origin are
15
assumed to be contaminated and do provide an ideal medium for the growth of
16
pathogenic organisms, they should not be available for consumer self-service.
17
Self-service operations of ready-to-eat foods also provide an opportunity for
18
contamination by consumers. The risk of contamination can be reduced by
19
supplying clean utensils and dispensers and by employee monitoring of
20
these operations to ensure that the utensils and dispensers are properly
21
used.
22
Bean sprouts that are displayed in produce areas for consumer self-service
23
are potentially hazardous foods (time/temperature control for safety foods) and
24
appropriate refrigeration
25
considered ready-to-eat since they are intended to be washed by the consumer
26
before consumption.
27
3-306.14
must
be
maintained.
However,
they
are
not
Returned Food and Re-Service or Sale.*
28
Food can serve as a means of person-to-person transmission of disease
29
agents such as hepatitis
30
goods in a bread basket that are not potentially hazardous (time/temperature
A virus.
Any unpackaged foods, even bakery
Guam Food Code Annex 1 – Public Health Reasons
109
1
control safety foods) and that have been served to a consumer, but not
2
eaten, can become vehicles for transmitting pathogenic microorganisms from the
3
initial consumer to the next if the food is served again.
4
Preventing
5
Contamination
6
from Other
7
Sources
8
This Code section provides a category in which to capture sources of
9
contamination not specifically delineated in Subparts 3-301 through 306.
10
Codes prior to 1993 had such a provision for addressing food contamination
11
for reasons other than those elsewhere specified.
12
specificity, a Code can not anticipate all the diverse means by which food
13
can become contaminated after receipt.
14
Cooking
3-307.11
Miscellaneous Sources of Contamination.
Regardless of its
3-401.11
Raw Animal Foods.*
15
3-401.12
Microwave Cooking.*
16
3-401.13
Plant Food Cooking for Hot Holding.
17
Cooking, to be effective in eliminating pathogens, must be adjusted to a
18
number of factors. These include the anticipated level of pathogenic bacteria
19
in the raw product, the initial temperature of the food, and the food's bulk
20
which affects the time to achieve the needed internal product temperature.
21
Other factors to be considered include post-cooking heat rise and the time
22
the food must be held at a specified internal temperature.
23
Greater numbers and varieties of pathogens generally are found on poultry
24
than
25
combination with the appropriate time is needed to cook these products.
26
To kill microorganisms, food must be held at a sufficient temperature for
27
the specified time. Cooking is a scheduled process in which each of a
28
series of continuous time/temperature combinations can be equally effective.
29
For example, in cooking a beef roast, the microbial lethality achieved at 112
30
minutes after it has reached 54.4°C (130°F) is the same lethality attained as
on other
raw
animal foods.
Therefore, a
higher
Guam Food Code Annex 1 – Public Health Reasons
110
temperature, in
1
if it were cooked for 4 minutes after it has reached 62.8°C (145°F). Cooked
2
beef and roast beef, including sectioned and formed roasts, chunked and
3
formed roasts, lamb roasts and cooked corned beef can be prepared using
4
one of the time and temperature combinations listed in the chart in
5
§ 3-401.11 to meet a 6.5-log10 reduction of Salmonella. The stated temperature
6
is the minimum that must be achieved and maintained in all parts of each
7
piece of meat for a least the stated time.
8
temperature
9
Guidelines For Meeting Lethality Performance Standards For Certain Meat And
The source of the time and
parameters is from the USDA/FSIS Appendix A. Compliance
10
Poultry Products found at http://www.fsis.usda.gov/oa/fr/95033F-a.htm.
11
Cooking requirements are based in part on the biology of pathogens.
12
thermal destruction of a microorganism is determined by its ability to survive
13
heat. Different species of microorganisms have different susceptibilities to
14
heat.
15
bacteria, the trophozoite of protozoa, or the larval form of worms) is less
16
resistant than the same organism's survival form (the bacterial spore,
17
protozoan cyst, or worm egg).
18
Food characteristics also affect the lethality of cooking temperatures.
19
penetrates into different foods at different rates. High fat content in food
20
reduces the effective lethality of heat.
21
vessel and the moisture content of food aid thermal destruction.
22
Heating a large roast too quickly with a high oven temperature may char or
23
dry the outside, creating a layer of insulation that shields the inside from
24
efficient heat penetration. To kill all pathogens in food, cooking must bring all
25
parts of the food up to the required temperatures for the correct length of
26
time.
27
The temperature and time combination criteria specified in Part 3-4 of this
28
Code are based on the destruction of Salmonellae. This organism, if present
29
in raw shell eggs, is generally found in relatively low numbers. Other foods,
30
uncomminuted fish and meats including commercially raised game animal
The
Also, the growing stage of a species (such as the vegetative cell of
High humidity within the cooking
Guam Food Code Annex 1 – Public Health Reasons
111
Heat
1
meat,
specified
as
2
parameter are expected to
3
parameters are expected to provide destruction of the surface contaminants
4
on these foods. Part 3-4 includes temperature and time parameters that
5
provide “D” values (decimal log reduction values) that may surpass 7D. For
6
example, at 63oC (145oF), a time span of 15 seconds will provide a 3D
7
reduction of Salmonella Enteritidis in eggs.
8
The requirements specified under ¶ 3-401.11(D) acknowledge the rights of an
9
informed consumer to order and consume foods as preferred by that
10
consumer based on the consumer‟s health status and understanding of the
11
risks associated with eating raw or partially-cooked animal foods.
12
In consumer self-service operations, such as buffets, salad bars, sushi bars, or
13
display cases, the consumer advisory as specified under section 3-603.11
14
must be posted or available at the self-service unit where the raw or
15
partially cooked food is held for service and readily accessible to consumers
16
prior to making their food selections.
17
wedding reception, guests are responsible for making their own requests or
18
selections.
19
Slow-cooked roasts - Heating Deviations and Slow Come Up Time
20
(Source: USDA/FSIS Appendix A Compliance Guidelines For Meeting Lethality
21
Performance Standards For Certain Meat And Poultry Products found at
22
http://www.fsis.usda.gov/oa/fr/95033F-a.htm
23
Heating
24
inordinate dwell time within the optimum temperature range for microorganism
25
growth can foster the multiplication of many pathogens. This multiplication
26
sometimes can be so prodigious that even recooking may be ineffective in
27
rendering
28
toxins
29
Staphylococcus aureus, are extremely heat stable and are not inactivated
30
by normal recooking temperatures.
deviations,
acceptable
which
the product.
cooking at this temperature and time
have a low level of internal contamination. The
the product safe.
into
for
In a catered situation, such as a
most often involve slow come-up time or an
Also, certain toxigenic bacteria can release
Some of
these toxins,
Guam Food Code Annex 1 – Public Health Reasons
112
such
as
those of
1
Further, the sampling of product following a heating deviation may not yield
2
sufficient information to determine the safety of the product in question.
3
Heating deviations can favor the multiplication of many types of bacteria. It
4
would be difficult and expensive to sample for all of them.
5
the circumstances, establishments may want to use computer modeling to
6
estimate the relative multiplication of bacteria. For example, in a past
7
incident involving an extreme heating deviation, product was put in an oven
8
in which the temperature was inadvertently set to 95°F for about 12 hours.
9
Computer modeling was easily applied in this case because much of the
10
dwell time was at one temperature. The USDA/FSIS determined that within a
11
6-hour time frame (with other growth conditions assumed to be favorable), the
12
relative multiplication of many pathogens of concern could have exceeded
13
5-logs. Clearly the product could not be salvaged by reprocessing and
14
was therefore destroyed.
15
however, computer modeling becomes more difficult. One approach is to
16
average lag/log times over
17
times to get
18
larger increment of time. Establishments must keep in mind that the
19
population of bacteria before processing
20
assumptions in the high range often are used as input parameters in the
21
modeling.
22
Seared Steak
23
The provision for allowing seared steaks was reviewed by the National
24
Advisory Committee for Microbiological Criteria for Foods (NACMCF) and
25
USDA. Paragraph 3-401.11(C) includes their recommendations.
26
USDA comments included, “For the purposes of this discussion, steak is
27
a whole beef muscle.
28
been pinned, injected, or chopped and formed.
29
such as sirloin, chuck, or porterhouse; or it may be cut with the grain, such
Depending on
Under changing conditions of
temperature,
small increments such as 5° and add these
an approximation of possible total relative
is
generally
growth over a
unknown and that
It does not include whole beef muscle that has
It may be cut cross grain,
Guam Food Code Annex 1 – Public Health Reasons
113
1
as flank, skirt, or Chateaubriand. Other species, such as poultry, pork, and
2
lamb are not included.”
3
NACMCF comments included, “Due to the low
4
organisms being present in or migrating from the external surface to the
5
interior of beef muscle, cuts of intact muscle (steaks) should be safe if the
6
external surfaces are exposed to temperatures sufficient to effect a cooked
7
color change.
8
additional heat to effect a complete sear across the cut surfaces. Grill or
9
char marks may be applied to the complete surface searing.
In addition, the
probability of
pathogenic
cut (exposed) surfaces must
receive
The meat
10
should be seared on both top and bottom surfaces utilizing a heating
11
environment (e.g., grill or broiling oven) that imparts a temperature at the
12
surface of the intact steak of at least 145oF to achieve a cooked color
13
change on all external surfaces. The searing of all surfaces should be
14
continuous until the desired degree of doneness and appearance are
15
attained. This is considered a ready-to-eat food.”
16
As reflected in the definition of “whole-muscle, intact beef steak,” marination
17
is a food safety concern when the fascia (exterior surface) of the steak is
18
broken by scoring or other means which allows the marinade to penetrate, and
19
potentially contaminate, the interior of the steak. In such cases, the Code
20
allowance for undercooking without a consumer advisory is negated.
21
Pork
22
In
23
parasites causing foodborne illness, are inactivated at temperatures below
24
145oF.
25
for 3 minutes) and pork chops cooked like steaks to achieve an internal
26
temperature of 145oF for 15 seconds.
27
Based on the Goodfellow and Brown study, a 5D reduction of organisms is
28
achieved at 68oC (155oF) for 15 seconds for the following foods: ratites and
29
injected meats and comminuted:
30
raised for food, and game animals that come under a USDA voluntary
pork, Trichinella
spiralis, Toxoplasma gondii, and Taenia solium,
Therefore, pork roasts can be cooked like beef roasts (e.g., 145oF
fish, meat, game animals commercially
Guam Food Code Annex 1 – Public Health Reasons
114
1
inspection program. Ratites such as ostrich, emu, and rhea are included in
2
this list of raw animals foods because when cooked to a temperature greater
3
than 68oC (155oF), ratites exhibit a (metallic) “off” taste.
4
When
5
CFR 318.23 Heat-Processing and Stabilization Requirements for Uncured Meat
6
Patties (known as the “patty rule”), the Agency based the 5D for Salmonella
7
on extrapolations applied to the research done by Goodfellow and Brown to
8
account for the lack of a “come up, come down” time in the thin, small
9
mass beef patties. Consequently, there is no linear relationship between the
10
patty rule and roast beef time and temperature parameters. The patty rule
11
also provided for an 8D reduction in the number of Shiga toxin-producing
12
Escherichia coli. The time and temperature requirements in the Food Code
13
for comminuted meats are comparable to the USDA requirements.
14
Temperature for Comminuted Meat at Less Than 1 Second
15
In the “Report of the Task Force on Technical Issues Arising from the
16
National Advisory Committee for Microbiological Criteria for Foods (NACMCF)
17
Review of the Meat Patty Proposal” (undated), it is stated on page 7, in
18
Option (A), that:
USDA
established
the
time and temperature parameters for
19
“Based on the 1998 research data ... and an assumption that
20
instantaneous is defined as eight seconds, manufacturers would
21
be
22
temperature of 157oF. Given the lack of any significant margin of
23
safety in this process, there should be no deviation below the
24
158oF requirement.”
required
to
process
fully-cooked
meat
patties
at
9
a
25
In November, 1997, the NACMCF Meat and Poultry Subcommittee revisited the time
26
and temperatures for cooking hamburger and advised FDA that cooking hamburger
27
to 158oF for less than one second is an adequate cook based on the following:
28
Guam Food Code Annex 1 – Public Health Reasons
115
1
1.
The cooking recommendations contained in the Food
2
Code and in USDA guidance provide a large margin of
3
safety for killing vegetative enteric pathogens;
4
2.
The concept of integrated lethality (the kill imparted during
5
the entire heating and cooling process) adds to the
6
margin of safety; and
7
3.
The time component of the time and temperature requirement
8
will
be
exceeded
9
determined.
before
the
temperature
can be
10
The parameters for cooking poultry, wild game animal meats, stuffed
food
11
products, etc., of 74oC (165oF) or above for 15 seconds yield greater than a
12
7D reduction.
13
3-401.12
14
The rapid increase in food temperature resulting
15
does not provide the same cumulative time and temperature relationship
16
necessary for the destruction of microorganisms as do conventional cooking
17
methods.
18
temperature of 74oC (165oF) in all parts of the food. Since cold spots may
19
exist in food cooking in a microwave oven, it is critical to measure the food
20
temperature at multiple sites when the food is removed from the oven and
21
then allow the food to stand covered for two minutes post microwave heating
22
to allow thermal equalization and exposure.
23
ovens are designed and engineered to deliver energy more evenly to the
24
food than others, the important factor is to measure and ensure that the final
25
temperature reaches 74oC (165oF) throughout the food.
26
“The factors that influence microwave thermal processes include many of the
27
same factors that are important in conventional processes (mass of objects,
28
shape of objects, specific heat and thermal conductivity, etc.).
29
other factors are unique in affecting microwave heating, due to the nature of
30
the electric field involved in causing molecular friction.
In
order
Microwave Cooking.*
from microwave heating
to achieve comparable lethality, the food must attain a
Although
Guam Food Code Annex 1 – Public Health Reasons
116
some microwave
However,
These factors are
1
exemplified by moisture and salt contents of foods, which play a far more
2
important
3
Heddelson and Doores, see 2005 Model Food Code Annex 2)
role
in
microwave
3-401.13
4
than conventional
heating.”
(Reference:
Plant Food Cooking for Hot Holding.
5
Fruits and vegetables that are fresh, frozen, or canned and that are heated
6
for hot holding need only to be cooked to the temperature required for hot
7
holding.
8
destruction as do raw animal foods since these fruits and vegetables are
9
ready-to-eat at any temperature. Cooking to the hot holding temperature of
10
57°C (135°F) prevents the growth of pathogenic bacteria that may be present
11
in or on these foods. In fact, the level of bacteria will be reduced over time at
12
the specified hot holding temperature.
13
Freezing
14
Refer to the public health reason for § 3-201.11.
15
Lightly cooked, raw, raw-marinated, and cold-smoked fish may be desired by
16
consumers for taste or perceived nutritional reasons.
17
destruction of parasites, fish may be frozen before service as an alternative
18
public health control to that which is provided by adequate cooking. Candling
19
or other visual inspection techniques are not adequate to avoid the risk of
20
parasites from fish which have not been frozen.
21
The recommended control strategies refer to the ambient air temperature
22
during freezing and to the length of time that the fish is held at the appropriate
23
freezer temperature, or the length of time that the fish is held after it is solid
24
frozen, whichever is appropriate. The parasite hazard is not considered to be
25
reasonably likely to occur if the finished product is fish eggs that have been
26
removed from the skein (the tissue that contains the egg mass) and rinsed.
27
In response to information provided to the FDA Office of Seafood, the Fish
28
and Fisheries Products Hazards and Controls Guidance lists certain species of
29
tuna as not being susceptible to parasites of concern and therefore
These
foods do
3-402.11
not require
the
same level of microorganism
Parasite Destruction.*
Guam Food Code Annex 1 – Public Health Reasons
117
In order to
ensure
1
exempted from the freezing requirements that apply to other fish species
2
that are consumed raw.
3
The Fish and Fisheries Products Hazards and Controls Guidance states that
4
species that normally have parasites as a result of consuming infected prey,
5
apparently do not have the same parasite hazard when raised on pelleted
6
food in an aquaculture operation. On the other hand, aquacultured fish that
7
are fed processing waste and by-catch fish may have a parasite hazard,
8
even when wild caught fish of that species do not normally have a parasite
9
hazard. Feed must not contain any live parasites. For example, the use of
10
fresh fish meat in feed could transmit such parasites. Only heat treated feed
11
or feed otherwise produced in a manner that would kill parasite intermediate
12
stages infective to the aquacultured fish, such as most pelleted
13
should be used.
3-402.12
14
feeds,
Records, Creation and Retention.
15
Records must be maintained to verify that the critical limits required for food
16
safety are being met. Records provide a check for both the operator and
17
the regulator in determining that monitoring and corrective actions have taken
18
place.
19
While the Country of Origin Labeling requirements, http://www.ams.usda.gov/COOL/
20
effective Sept. 30, 2004, mandate identification of wild and farm-raised fish and
21
shellfish, the requirements do not address contents of pelleted feed used in the
22
aquaculture operation.
23
establishment from the source-through-purchase specifications or labeling that
24
pelleted feed used did not contain fresh fish or plankton. Follow the guidance
25
provided in The Fish and Fisheries Products Hazards and Controls Guidance
26
Table #3-1 - Potential Vertebrate Species Related Hazards and Table #3-2 -
27
Potential Invertebrate Species Related Hazards.
28
Reheating
29
When food is held, cooled, and reheated in a food establishment, there is an
30
increased risk
3-403.11
from
Documentation
must be available in the food
Reheating for Hot Holding.*
contamination
caused
by
personnel,
Guam Food Code Annex 1 – Public Health Reasons
118
equipment,
1
procedures,
or other factors.
If food is held at improper temperatures for
2
enough time, pathogens have the opportunity to multiply to dangerous numbers.
3
Proper reheating provides a major degree of assurance that pathogens will be
4
eliminated. It is especially effective in reducing the numbers of Clostridium
5
perfringens that may grow in meat, poultry, or gravy if these products were
6
improperly cooled.
7
illness when they grow to high numbers.
8
spores will survive cooking and hot holding. If food is abused by being held at
9
improper holding temperatures or improperly cooled, spores can germinate to
Vegetative cells of C. perfringens can cause foodborne
Highly resistant C. perfringens
10
become rapidly multiplying vegetative cells.
11
Although proper reheating will kill most organisms of concern, some toxins
12
such as that produced by Staphylococcus aureus, cannot be inactivated
13
through reheating of the food. It is imperative that food contamination be
14
minimized to avoid this risk.
15
The potential for growth of pathogenic bacteria is greater in reheated cooked
16
foods than in raw foods. This is because spoilage bacteria, which inhibit the
17
growth of pathogens by competition on raw product, are killed during cooking.
18
Subsequent recontamination will allow pathogens to grow without competition if
19
temperature abuse occurs.
20
Refer also to the public health reason for § 3-401.12.
3-404.11
21
Treating Juice.
22
Refer to the public health reason for § 3-801.11.
23
Temperature and
3-501.11
Frozen Food.
Guam Food Code Annex 1 – Public Health Reasons
119
1
3-501.12
Time Control
Potentially Hazardous Food
2
(Time/Temperature Control for Safety
3
Food), Slacking.
3-501.13
4
Thawing.
5
Freezing prevents microbial growth in foods, but usually does not destroy all
6
microorganisms. Improper thawing provides an opportunity for surviving
7
bacteria to grow to harmful numbers and/or produce toxins. If the food is
8
then refrozen, significant numbers of bacteria and/or all preformed toxins are
9
preserved.
3-501.14
10
Cooling.*
11
Safe cooling requires removing heat from
food quickly enough to prevent
12
microbial growth. Excessive time for cooling of potentially hazardous foods
13
(time/temperature control for safety foods) has been consistently identified as
14
one of the leading contributing factors to foodborne illness.
15
cooling, potentially hazardous foods (time/temperature control for safety foods)
16
are subject to the growth of a variety of pathogenic microorganisms.
17
longer time near ideal bacterial incubation temperatures, 21 C - 52 C (70 F -
18
125oF), is to be avoided. If the food is not cooled in accordance with this
19
Code requirement, pathogens
20
foodborne illness.
21
The Food Code provision for cooling provides for cooling from 135ºF to 41 F or
22
45 F in 6 hours, with cooling from 135ºF to 70 F in 2 hours. The 6-hour cooling
23
parameter, with an initial 2-hour rapid cool, allows for greater flexibility in
24
meeting the Code. The initial 2-hour cool is a critical element of this cooling
25
process. An example of proper cooling might involve cooling from 135ºF to
26
70ºF in 1 hour, in which case 5 hours remain for cooling from 70ºF to
27
41ºF or 45ºF.
28
achieved in 6 hours, but the initial cooling to 70ºF took 3 hours, the food
29
safety hazards may not be adequately controlled.
During slow
o
may
grow
to
o
sufficient numbers to cause
Conversely, if cooling from 135ºF to 41 F
Guam Food Code Annex 1 – Public Health Reasons
120
o
A
or
45 F is
1
If the cooking step prior to cooling is adequate and no recontamination
2
occurs,
3
perfringens or Bacillus cereus should be killed or inactivated. However,
4
under substandard sanitary conditions, other pathogens such as Salmonella
5
or
6
requirements are based on growth
7
survive or be a post-cook contaminate and grow rapidly under temperature
8
abuse conditions.
9
Shell Eggs
all
Listeria
but
the
spore-forming
monocytogenes
organisms
may
be
such
reintroduced.
as
Clostridium
Thus,
cooling
characteristics of organisms that may
10
FDA has approved the use of ionizing radiation for shell eggs.
11
approval means that FDA has not found the ionizing radiation process to be
12
unsafe for shell eggs. However, shell eggs that have been subjected to the
13
approved
14
pasteurized.
15
subjected to a 5-log kill process for Salmonella Enteritidis, while the
16
approved ionizing radiation process may deliver only 2 or 3 logs reduction.
17
Therefore, eggs treated by ionizing radiation process alone must be held
18
under refrigeration, as it cannot be guaranteed that Salmonella Enteritidis
19
will be eliminated in all treated eggs.
20
labeled in accordance with 21 CFR 179.26 Ionizing radiation for the treatment
21
of food.
22
Hard-boiled eggs with shell intact may be cooled in ambient air and are not
23
considered to be a potentially hazardous food (time/temperature control for
24
safety food) after cooling. Hard-boiled eggs may be cooled in drinking water
25
but are considered to be a potentially hazardous food (time/temperature
26
control for safety food) after cooling because pathogens, which may be
27
present in the water, may pass through the egg shell during cooling.
28
Salmonella Enteritidis has been shown to have an extended lag phase in
29
shell eggs due to inhibitory characteristics of the albumen.
30
indicates that the organisms are physically located near the exterior of the
ionizing
radiation process
Shell egg
are
not
This
considered to have been
pasteurization requires the egg to have been
Further, irradiated eggs must be
Guam Food Code Annex 1 – Public Health Reasons
121
Research
1
yolk membrane, in contact with the bacteriostatic components. Growth does
2
not appear until the yolk membrane is weakened by age or physically
3
breached and the yolk nutrients, such as iron, become available to the
4
organisms.
5
Federal
6
transported and distributed under refrigeration at an ambient temperature not
7
to exceed 45°F.
8
refrigeration is required.
9
required to include a certification that the eggs, at all times after packing,
10
have been stored and transported at an ambient temperature of no greater
11
than 45°F.
12
On December 5, 2000, federal regulations
13
shell egg cartons bear safe handling instructions and be placed under
14
refrigeration at 45° F or lower upon delivery at retail establishments (65 FR
15
76091, December 5, 2000, Food Labeling, Safe Handling Statements,
16
Labeling
17
Distribution). The amended provisions include:
regulations
of
Shell
effective
August 27, 1999, require shell eggs to be
Packed shell eggs must be labeled indicating that
Imported shell eggs packed for consumer use are
Eggs;
Refrigeration
were amended to require that
of
Shell
Eggs
Held for Retail
18
21 CFR Part 16 Regulatory Hearing before the Food and Drug
19
Administration, § 16.5.
20
A hearing on an order for re-labeling, diversion or destruction
21
of shell eggs…
22
21 CFR Part 101 Food Labeling § 101.17.
23
warning, notice, and safe handling statements, ( h) Shell eggs.
24
21 CFR Part 115 Shell Eggs, § 115.50 Refrigeration of shell
25
eggs held for retail distribution.
Inapplicability and limited applicability, (4)
Food labeling
26
Shell eggs must be placed immediately after receipt in refrigerated equipment
27
that is capable of maintaining an ambient air temperature of 45°F.
28
the newly established Federal requirement for eggs to be in an ambient
29
storage and transportation temperature of 45°F, and with refrigeration of
30
eggs at retail as described above, the overall time that eggs are stored at
Guam Food Code Annex 1 – Public Health Reasons
122
With
1
temperatures that allow the growth of Salmonella spp. should be shortened.
2
Additionally, this requirement negates the need to “cool” shell eggs upon
3
receipt, although food establishment operators should maximize the circulation
4
of cooled air in refrigeration units by separating flats, cases, and multiple
5
cartons of eggs.
CFSAN/FSIS Joint Position Paper on Cooling
6
7
The processing
of most ready-to-eat products includes a heat treatment or
8
cooking step to eliminate pathogenic and spoilage microorganisms. However,
9
this heat treatment does not eliminate spores of Clostridium botulinum and
10
Clostridium perfringens and other spore-forming bacteria. Furthermore, these
11
organisms can thrive in the warm product since other competing organisms
12
have been eliminated. Non-refrigerated, anaerobic conditions are conducive
13
to their growth and multiplication.
14
To prevent the growth and multiplication of spore-forming organisms, product
15
should be
16
cooling, spores can germinate and the resulting vegetative cells can multiply
17
to hazardous levels. The presence of sufficient numbers of C. botulinum or
18
other
19
Therefore, ensuring no growth of these organisms will provide the greatest
20
amount of safety.
21
The USDA/FSIS Performance Standards for the Production of Certain Meat
22
and Poultry Products require a stabilization step (cooling) after the lethality
23
step. The stabilization requirements allow for no growth of C. botulinum
24
and no more than 1 log growth of C. perfringens.
25
standard of no more than 1 log growth of C. perfringens was based on the
26
following reasons:
27
1.
cooled rapidly after cooking.
spore-forming
When
there
is
inadequate
organisms may lead to production of harmful toxins.
The performance
The Centers for Disease Control and Prevention (CDC) suggested viable
28
counts of 105 or greater of C. perfringens per gram as one of the criteria for
29
incriminating C. perfringens as a causative agent of foodborne illness in
30
finished product. However, foods responsible for C. perfringens outbreaks
Guam Food Code Annex 1 – Public Health Reasons
123
1
were found usually to contain 106 vegetative C. perfringens cells per gram.
2
In
3
contain more than 1000
4
probability that greater than 104 C. perfringens per gram can occur in the
5
raw product on rare occasions. It is a conservative assumption that the
6
great majority of C. perfringens in the raw product are spores.
7
2.
FSIS microbiological raw product surveys, samples were found to
C. perfringens per gram. There is some
Heating activates spores that, during cooling, become vegetative cells that
If there are more than 104 C.
8
can multiply to hazardous levels.
9
perfringens (spores) per gram on raw product, it is possible that there
10
may be more than 104 vegetative C. perfringens per gram in the product
11
if it is improperly cooled after cooking.
12
3.
Based on the CDC recommended upper limit of 105 which should not be
13
exceeded, it was determined that a limit of no more than 1 log10 growth
14
of C. perfringens would be appropriate to ensure that there would be no
15
more than 105 C. perfringens per gram on the finished product after
16
cooling.
17
4.
The
performance standard was discussed with experts on clostridia
18
research.
The experts agreed that limiting the relative growth of C.
19
perfringens to no more than 1 log10 would be reasonable and somewhat
20
conservative with respect to product safety. (64 FR 732, January 6, 1999,
21
Performance Standards for the Production of Certain Meat and Meat
22
Products).
23
The FSIS compliance guideline for the cooling performance standards, which
24
can
25
Guidelines for Cooling Heat-Treated Meat and Poultry Products (Stabilization),
26
is that product must be cooled from 130ºF to 80 F in 1.5 hours and from
27
80ºF to 40 F in 5 hours. This cooling rate can be applied universally to
28
cooked products like partially cooked or fully cooked, intact or non-intact
29
meat and poultry products.
30
cooling of
be
found
at
http://www.fsis.usda.gov/oa/fr/95033F-b.htm Compliance
the product
The guideline results in continuous and rapid
in the temperature range where the spore-forming
Guam Food Code Annex 1 – Public Health Reasons
124
1
organisms can grow rapidly.
2
The former USDA guideline of cooling from 120ºF to 55 F in no more
3
than 6 hours is also included in the new compliance guidelines.
4
this guideline, chilling should begin within 90 minutes after the cooking cycle
5
is completed, and cooling should continue until product reaches 40 F. The
6
6-hour rule begins when the product reaches 120ºF, and product should not
7
be shipped until the product reaches 40 F.
8
results in a significantly smaller margin of safety, especially if the product is
9
non-intact. In using this older guideline, the establishment has to ensure that
10
cooling is as rapid as possible, especially between 120ºF and 80 F, and
11
should monitor the cooling closely to prevent any deviation. If product remains
12
between these temperatures for more
13
performance standard is less certain.
14
The FSIS cooling guideline for meat and poultry products containing 100
15
ppm added nitrite is 130ºF to 80 F in 5 hours and from 80ºF to 45 F in 10
16
hours, a total of 15 hours cooling time. This cooling process provides a
17
narrow margin of safety. In case of cooling deviations,
18
should assume that their process has exceeded the performance standard
19
for controlling the growth of C. perfringens, and should take corrective
20
action. However, the presence of nitrite should ensure compliance with
21
the performance standard for C. botulinum.
22
The Food Code provision for cooling is similar, though not identical to
23
the FSIS cooling compliance guidelines.
24
to 70 F in 2 hours and from 135ºF to 41 F or 45 F in 6 hours and is
25
based on the same food safety concerns as FSIS‟ guidance. The Food
26
Code provides prescriptive cooling time/temperature combinations without a
27
HACCP plan in place. Federally inspected meat and poultry establishments
28
are required to implement a HACCP plan for their operations.
29
The
30
recommended that FSIS and FDA ask the National Advisory Committee on
Conference
for
Food
than
This older cooling guideline
an
hour, compliance with the
the establishment
It provides for cooling from 135ºF
Protection
(CFP) at
Guam Food Code Annex 1 – Public Health Reasons
125
In using
its
2000
meeting
1
Microbiological Criteria for Foods (NACMCF) to review the data on safe
2
cooling
3
control for safety foods).
4
submitted to the CFP, showing that cooling of a meat product from 130ºF to
5
45 F can safely take place in 15 hours based on a study by V.K. Juneja, et
6
al., 1994.
7
meat product from 130ºF to 45 F in 15 hours permitted about 1 log growth
8
of C. perfringens.
9
In response to the CFP recommendation, the FSIS Administrator and CFSAN
10
agreed that the data referenced in the CFP recommendation do not support
11
a change in the FSIS guidance or
12
considered it inadvisable to ask the NACMCF to undertake the task
13
requested for several reasons:
14
1.
The study did not address growth of C. botulinum.
15
2.
The results are from a carefully controlled laboratory study in which
times for cooked, potentially hazardous foods (time/temperature
The review would include data from a study,
According to the authors of the study, continuous cooling of a
the Food Code § 3-501.14 and
16
cooling of the product was steady and continuous, conditions difficult to
17
maintain in most commercial processing or retail environments even with
18
data loggers and other control mechanisms in place.
19
3.
The study was done only on ground beef and may not be applicable to
20
other meat and poultry or to other potentially hazardous
21
(time/temperature control for safety foods).
foods
22
As an alternative response, CFSAN and FSIS advised CFP that they would
23
provide
24
cooling issues.
this written position paper to clarify their joint position on the
3-501.15
25
Cooling Methods.
26
Large food items, such as roasts, turkeys, and large containers of rice or
27
refried beans, take longer to cool because of the mass and volume from
28
which heat must be removed.
29
individual container,
30
opportunity for pathogen growth is minimized. If the hot food container is
By reducing the volume of the food in an
the rate of cooling is dramatically increased and
Guam Food Code Annex 1 – Public Health Reasons
126
1
tightly covered, the rate of heat transfer is reduced, i.e., the time required
2
for cooling and the time the food is exposed to optimal temperatures for
3
bacterial multiplication or toxin production are increased.
4
Alternatives to conventional methods include avoiding the need to cool
5
larger masses by preparing smaller batches closer to periods of service or
6
chilling while stirring hot food in containers within an ice water bath.
7
Commercial
8
temperatures, not cool large masses of food. Rapid chilling equipment is
9
designed to cool the food to acceptable temperatures quickly by using very
10
refrigeration
equipment
is
designed
to hold cold food
low temperatures and high rates of air circulation.
3-501.16
11
Potentially Hazardous Food (Time/Temperature
Control for Safety Food), Hot and Cold Holding.*
12
13
Bacterial growth and/or toxin production can occur if potentially hazardous
14
food (time/temperature control for safety food) remains in the temperature
15
“Danger Zone” of 5oC to 57oC (41oF to 135oF) too long.
16
rate of growth increases with an increase in temperature within this zone.
17
Beyond the upper limit of the optimal temperature range for a particular
18
organism, the rate of growth decreases.
19
cooling of food should be performed as rapidly as possible to avoid the
20
possibility of bacterial growth.
21
Cold Holding
22
Except for raw shell eggs, control of the growth of Listeria monocytogenes
23
(Lm)
24
combinations in
25
addition to temperature, as a control for the growth of Lm in refrigerated,
26
ready-to-eat, potentially hazardous food (time/temperature control for safety
27
food).
28
conditions that allow 1 log of growth of Lm, and do not set an acceptable
29
number of Lm in food. Neither do they imply that Lm is in the product.
30
The times and temperatures in the 1999 Food Code were based on the
is
Up to a point, the
Operations requiring heating or
the basis for the list of cold holding temperature and time
paragraph
3-501.17(A).
The list addresses time,
in
The Code provisions for cold holding focus on environmental
Guam Food Code Annex 1 – Public Health Reasons
127
1
USDA
Pathogen Modeling Program (PMP), which is conservative in
2
estimating
3
based largely on observations of microbial growth in broth cultures, but
4
some observations in specific foods were also included. The PMP allows
5
for some variation in temperature, pH,
6
conservative estimate of safe times and temperatures for holding foods. The
7
1999 Food Code estimated safe times and temperatures that would allow 3
8
logs of growth, based on the PMP.
9
During 2000, CFSAN researched published literature and compiled a listing
10
of the growth potential of Lm in various food commodities using real food
11
data.
12
temperatures of 41ºF for 7 days and 45ºF for 4 days were validated, but
13
the underlying performance standard changed for the commodities studied.
14
The research-based, food-specific times and temperatures allow no more
15
than 1 log of growth instead of the 3 log growth predicted in the PMP.
16
This more stringent performance standard of 1 log is consistent with the
17
USDA/FSIS performance standard and the fact that the infectious dose of
18
Lm remains unknown.
19
FDA concluded that the 1999 Code time/temperature criteria hold true and
20
provide both a greater level of safety and a more realistic basis for
21
regulatory requirements without compromising public health protection.
22
In
23
released
24
from Foodborne Listeria monocytogenes Among Selected Categories of Ready-
25
to-Eat Foods (risk assessment). This initiative included the development of
26
23 separate risk assessments and analysis of the relative risks of serious
27
illness and death associated with consumption of 23 categories of ready-to-
28
eat foods. These categories included: seafood, produce, meats, dairy
29
products, and deli salads.
30
The risk assessment identified several broad factors that affect
how soon Lm begins to grow and how fast.
Based on
The PMP was
and water activity, and gives a
this information, the 1999 Food Code times and
October 2003, FDA, in cooperation with the USDA/FSIS and CDC,
the Quantitative Assessment of the Relative Risk to Public Health
Guam Food Code Annex 1 – Public Health Reasons
128
consumer
1
exposure
to Lm
at
the time of food consumption.
Two of these factors,
2
refrigerated storage temperature and duration of refrigerated storage before
3
consumption, have a direct bearing on cold
4
combinations used in food establishments.
5
FDA continues to have concerns about the potential for growth of Lm in
6
refrigerated, ready-to-eat, potentially hazardous food (time/temperature control
7
for safety food), prepared and packaged in a food processing plant and held
8
in a food establishment.
9
Annex 3 3-501.16 Table 1) show a significant reduction in the projected cases
holding
time/temperature
Data from the risk assessment (see the following
10
of listeriosis when refrigerated storage is limited to 41ºF.
11
data
12
recommend
13
hazardous
14
maximum temperature of 41ºF.
and
conclusions
that
from the
risk
Based on these
assessment, FDA
continues to
food establishments limit the cold storage of potentially
(time/temperature
control
for
safety),
ready-to-eat foods to a
15
16
3-501.16 – Table 1. Estimated Reduction of Cases of Listeriosis from
17
Limits on Refrigeration Temperatures*
18
19
Maximum Refrigerator
20
Temperature
Cases of Listeriosisa
21
Median
5th Percentile
95th Percentile
Baselineb
2105
3/4c
3/4c
25
7 ˚C (45 ˚F) maximum
656
331
761
26
5 ˚C (41 ˚F) maximum
28
1
126
22
23
24
Guam Food Code Annex 1 – Public Health Reasons
129
1
2
3
4
5
6
7
8
9
10
a
Values for the median, upper and lower uncertainty levels.
b
The baseline uses the full empirical distribution of refrigerator temperatures from the Audits
International (1999) survey.
c
The baseline number of cases of listeriosis is fixed based on CDC surveillance data.
*The scenario assumed the distribution of storage times is the same for all three temperature sets.
Source: Quantitative Assessment of the Relative Risk to Public Health from Foodborne Listeria
monocytogenes Among Selected Categories of Ready-to-Eat Foods September 2003. Table VI-1.
Estimated Reduction of Cases of Listeriosis from Limits on Refrigeration Temperatures.
11
12
Regarding shell eggs, USDA published a final rule (63 FR 45663, August 27,
13
1998 Refrigeration and Labeling Requirements for Shell Eggs) to require that
14
shell eggs packed for consumer use be stored and transported at an ambient
15
temperature not to exceed 7ºC (45ºF). This regulation, however, does not apply
16
to eggs while held at all retail establishments.
17
without continued refrigeration up until the time that the eggs are cooked,
18
there would be an opportunity for the egg's defenses to degrade and growth of
19
Salmonella Enteritidis to occur. The agency reviewed research indicating that
20
Salmonella Enteritidis multiplies at temperatures of 10ºC (50ºF) and above
21
but can be inhibited at lower temperatures, e.g., 8ºC (46ºF), 7ºC (45ºF), and
22
4ºC (39ºF). Based on this research and USDA's temperature requirement
23
during transport, FDA implemented regulations that establish a maximum
24
ambient air temperature of 7ºC (45ºF) for eggs stored and displayed at retail
25
establishments. Amended Federal regulations 21 CFR Part 115.50 issued on
26
December 5, 2000 and became effective on June 4, 2001.
27
Although Congress did not expressly preempt State law in this area, FDA
28
found preemption is needed because State and local laws that are less
29
stringent than the Federal requirements will not support the important public
30
health goals of these regulations. FDA does not believe that preemption of
31
State and local refrigeration and labeling requirements that are the same as
32
or more stringent than the requirements of these regulations is necessary,
FDA
Guam Food Code Annex 1 – Public Health Reasons
130
is concerned that
1
as enforcement of such State and local requirements will support the food
2
safety goals of these regulations. Accordingly, the preemptive effect of this
3
rule is limited to State or local requirements that are not as stringent as the
4
requirements of these regulations; requirements that are the same as or
5
more stringent than FDA's requirements remain in effect.
6
Hot Holding
7
In a January 2001 report, the National Advisory Committee on Microbiological
8
Criteria for Foods (NACMCF) recommended that the minimum hot holding
9
temperature specified in the Food Code:
10
Be greater than the upper limit of the range of temperatures at
11
which Clostridium perfringens and Bacillus cereus may grow;
12
and
13
Provide a margin of safety that accounts for variations in food
14
matrices, variations in temperature throughout a food product,
15
and
16
maintain product at a desired target temperature.
the capability
of hot holding equipment
to
consistently
17
C. perfringens has been reported to grow at temperatures up to 52°C
18
(126°F). Growth at this upper limit requires anaerobic conditions and follows
19
a lag phase of at least several hours. The literature shows that lag phase
20
duration and generation times are shorter at incubation temperatures below
21
49°C (120°F) than at 52°C (125°F). Studies also suggest that temperatures
22
that preclude the growth of C. perfringens also preclude the growth of B.
23
cereus.
24
CDC estimates that approximately 250,000 foodborne illness cases can be
25
attributed to C. perfringens and B. cereus each year in the United States.
26
These spore-forming pathogens have been implicated in foodborne illness
27
outbreaks associated with foods held at improper temperatures.
28
suggests that preventing the growth of these organisms in food by maintaining
29
adequate hot holding temperatures is an important public health intervention.
30
Taking into consideration the recommendations of NACMCF and the 2002
Guam Food Code Annex 1 – Public Health Reasons
131
This
1
Conference for Food Protection meeting, FDA believes that maintaining food
2
at a temperature of 57°C (135°F) or greater during hot holding is sufficient to
3
prevent the growth of pathogens and is therefore an effective measure in the
4
prevention of foodborne illness.
3-501.17
5
Ready-to-Eat, Potentially Hazardous Food
6
(Time/Temperature Control for Safety Food),
7
Date Marking.*
3-501.18
8
Ready-to-Eat, Potentially Hazardous Food
(Time/Temperature Control for Safety Food),
9
Disposition.*
10
11
Refer to Annex 7, Chart 4-C.
12
Refrigeration prevents food from becoming a hazard by significantly slowing the
13
growth of most microbes.
14
monocytogenes, is significantly slowed but not stopped by refrigeration.
15
Over a period of time, this and similar organisms may increase their risk to
16
public health in ready-to-eat foods.
17
The date by which the food must be consumed takes into consideration the
18
differences in growth of Listeria monocytogenes at 5oC (41oF) and 7oC
19
(45oF).
20
monocytogenes, ready-to-eat, potentially hazardous food (time/temperature
21
control for safety food) may be kept at 5 C (41 F) a total of 7 days or at 7 C
22
(45oF)
23
consumption is shortened for food in refrigerators incapable of maintaining
24
food at 5 C (41 F) but capable of maintaining it at 7 C (45 F) or below. Food
25
which is prepared and held, or prepared, frozen, and thawed must be
26
controlled by date marking to ensure its safety based on the total amount of
27
time it was held at refrigeration temperature, and the opportunity for Listeria
28
monocytogenes to multiply, before freezing and after thawing.
29
hazardous (time/temperature control for safety) refrigerated foods must be
30
consumed, sold or discarded by the expiration date.
The growth of some bacteria, such as Listeria
Based on a predictive growth curve modeling program for Listeria
o
a total of 4
o
days.
Therefore,
o
o
the period of time allowed before
o
o
Guam Food Code Annex 1 – Public Health Reasons
132
o
Potentially
1
Date marking is the mechanism by which the Food Code requires active
2
managerial control of the temperature and time combinations for cold holding.
3
Industry must implement a system of identifying the date or day by which the
4
food must be consumed, sold, or discarded.
5
apply to containers of processed food that have been opened and to food
6
prepared by a food establishment, in both cases if held for more than 24
7
hours, and while the food is under the control of the food establishment. This
8
provision applies to both bulk and display containers. It is not the intent of
9
the Food Code to require date marking on the labels of consumer size
Date marking requirements
10
packages.
11
A date marking system may be used which places information on the food,
12
such as on an overwrap or on the food container, which identifies the first
13
day of preparation, or alternatively, may identify the last day that the food
14
may be sold or consumed on the premises. A date marking system may use
15
calendar dates, days of the week, color-coded marks, or other effective
16
means, provided the system is disclosed to the Regulatory Authority upon
17
request, during inspections.
18
FDA/USDA/CDC Listeria monocytogenes Risk Assessment
19
In September, 2003, FDA, in cooperation with USDA/FSIS and CDC,
20
released the Quantitative Assessment of the Relative Risk to Public Health from
21
Foodborne Listeria monocytogenes Among Selected Categories of Ready-to-Eat
22
Foods.
23
assessments and analysis of the relative risks of serious illness and death
24
associated with consumption of 23 categories of ready-to-eat foods.
25
categories included: seafood, produce, meats, dairy products, and deli
26
salads.
27
In
28
measuring the public health impact to consumers from foodborne listeriosis.
29
These factors are: (1) amounts and frequency of consumption of a ready-to-
30
eat food; (2) frequency and levels of L. monocytogenes in a ready-to-eat
This
examining
initiative
these
included
closely,
the
development
of
23 separate risk
These
FDA showed that 5 factors are important in
Guam Food Code Annex 1 – Public Health Reasons
133
1
food; (3)
potential of the food to support growth of the bacterium during
2
refrigeration;
3
refrigerated storage before consumption.
4
Based on these 5 factors, the 23 categories of ready-to-eat foods were
5
ranked according to their relative risk of contamination and growth of Listeria
6
monocytogenes.
7
moderate risk; low risk; and very low risk.
(4)
refrigerated
storage
temperature;
and (5) duration of
The risk categories used were: very high risk; high risk;
8
Impact of the Listeria monocytogenes Risk Assessment on Date
9
Marking
10
Based on the results of the risk assessment and the recommendations
11
from the 2004 Conference for Food Protection meeting, it was necessary
12
to re-evaluate date marking in an effort to focus the provision on very
13
high and high risk foods, while at the same time, exempting foods that
14
present a very low, or low risk of contamination and growth of Listeria
15
monocytogenes. Based on this evaluation, date marking provisions of
16
the Food Code do not apply to the following foods:
17
Deli Salads Prepared and Packaged in a Food Processing Plant
18
Examples of deli salads include ham salad, chicken salad, egg salad, seafood
19
salad, pasta salad, potato salad, and macaroni salad, manufactured
20
according
21
assessment, deli salads prepared and packaged by a food processing
22
plant contain sufficient acidity, along with the addition of preservatives (e.g.,
23
sorbate, benzoates), to prevent the growth of Listeria monocytogenes.
24
There are estimates that 85% of all deli salads are prepared and
25
packaged in a food processing plant and do not support growth. Based
26
on discussions with deli salad manufacturers and trade associations, it is a
27
nearly universal practice for food processing plants preparing and packaging
28
deli salads to add one or more preservatives that inhibit the growth of
29
Listeria monocytogenes. Based on their wide use within this segment of
30
the industry and their effectiveness at inhibiting the growth of Listeria
to
21 CFR 110.
According
to
Guam Food Code Annex 1 – Public Health Reasons
134
data
from
the
risk
1
monocytogenes, all deli salads prepared and packaged in a food
2
processing plant are exempt
3
salads prepared in a food establishment require date marking.
4
Hard and Semi-Soft Cheeses
5
In December, 1999, FDA issued an exemption from date marking for
6
certain
7
(http://www.cfsan.fda.gov/~ear/ret-chdt.html), based on the presence of
8
several factors that may control the growth of Listeria monocytogenes.
9
These factors may include organic acids, preservatives, competing
types
of
from date marking. However, all deli
hard
and
semi-soft
cheeses
10
microorganisms, pH, water activity, or salt concentration.
11
the risk assessment support this interpretation and therefore, hard and
12
semi-soft cheeses each manufactured according to 21 CFR 133 are
13
exempt from date marking.
Guam Food Code Annex 1 – Public Health Reasons
135
The results of
1
List of Some Hard and Semi-Soft Cheeses Exempt from Datemarking
2
Asadero
Asiago soft
3
Abertam
Battelmatt
4
Appenzeller
Bellelay (blue veined)
5
Asiago medium or old
Blue
6
Bra
Brick
7
Cheddar
Camosum
8
Cristalina
Chantelle
9
Colby
Edam
10
Cotija Anejo
Fontina
11
Cotija
Gorgonzola (blue veined)
12
Coon
Gouda
13
Derby
Havarti
14
Emmentaler
Konigskase
15
English Dairy
Limburger
16
Gex (blue veined)
Milano
17
Gloucester
Manchego
18
Gjetost
Monterey
19
Gruyere
Muenster
20
Herve
Oka
21
Lapland
Port du Salut
22
Lorraine
Provolone
23
Oaxaca
Queso de Bola
24
Parmesan
Queso de la Tierra
25
Pecorino
Robbiole
26
Queso Anejo
Roquefort (blue veined)
27
Queso Chihuahua
Samsoe
28
Queso de Prensa
Tilsiter
29
Romanello
Trappist
Guam Food Code Annex 1 – Public Health Reasons
136
1
Romano
2
Reggiano
3
Sapsago
4
Sassenage (blue veined)
5
Stilton (blue veined)
6
Swiss
7
Tignard (blue veined)
8
Vize
9
Wensleydale (blue veined)
10
Cultured Dairy Products
11
Cultured dairy products include yogurt, sour cream, and buttermilk, each
12
manufactured according to 21 CFR 131. Many of these products often are
13
low pH foods manufactured with lactic acid fermentation. Data from the risk
14
assessment show that Listeria monocytogenes does not grow in these
15
foods and therefore, these products are exempt from date marking.
16
Preserved Fish Products
17
Preserved fish products include pickled herring and dried, or salted cod,
18
and other acidified fish products, manufactured according to 21 CFR 114.
19
Data from the risk assessment show that the high salt and/or acidity of
20
these products does not allow for the growth of Listeria monocytogenes
21
and therefore,
22
exemption does not apply to hot or cold smoked fish products, nor does it
23
apply to fish products that are dried, marinated, or otherwise preserved on-
24
site, in a food establishment, such as ceviche.
these products are exempt from date marking. This
25
USDA-regulated products
26
Date marking provisions of the Food Code do not apply to shelf stable
27
ready-to-eat meat and poultry products. Shelf stable ready-to-eat meat and
28
poultry
29
Refrigerated.” For these products, the nitrite and salt in the cure and the
30
lower pH resulting from fermentation give additional protection against microbial
products
are
not
required
by
USDA
to
Guam Food Code Annex 1 – Public Health Reasons
137
be
labeled
“Keep
1
growth. Some fermented sausages and salt-cured products are shelf stable, do
2
not require refrigeration, and do not bear the label “Keep Refrigerated.” To
3
be shelf stable, a product manufactured under USDA inspection must have
4
a
5
objective criteria for shelf stability, such as water activity, moisture-protein
6
ratio (MPR), or combination of MPR and pH (acidity). Therefore they are
7
exempt from the Food Code date marking requirements.
8
Shelf stable fermented sausages such as pepperoni and dry salami do not
9
have to be refrigerated or date marked. Shelf stable salt-cured products such
10
as prosciutto, country cured ham, or Parma ham do not require refrigeration or
11
Food
12
breasaola, coppa, and capocolla.
13
Some ready-to-eat fermented sausages and salt-cured products must be
14
refrigerated and therefore bear the USDA-required label “Keep Refrigerated.”
15
Examples of these products are cooked bologna, cooked salami, and sliced
16
country
17
refrigeration. Bologna is a cooked, perishable sausage and there are other
18
salamis, e.g., cotto that are perishable.
19
Regarding the exemption from date marking for shelf-stable sausages in a
20
casing, the exemption does not apply if the casing is removed. The intact
21
casing on shelf-stable sausages may be overwrapped to protect the cut face
22
of the sausage. With shelf stable (not potentially hazardous (time/temperature
23
control safety)) sausages, the intact casing provides a barrier to contamination
24
(although not an absolute one), the exposed face is likely to be sliced again
25
within 4 or 7 days, and contamination is minimized because only the face is
26
exposed. The coagulated protein that occurs on the surface of some
27
nonshelf stable cooked sausages is not a casing.
28
Slices of cured and fermented sausages that require refrigeration and are kept
29
for 24 hours or longer do need to be date marked.
30
If open dating information is applied to lunchmeats at a federally inspected
process that results in a product that meets one of the recognized
Code
date
ham which
marking.
Other salt-cured products include basturma,
are ready-to-eat
fermented
products
Guam Food Code Annex 1 – Public Health Reasons
138
that
need
1
meat
2
requirements in 9 CFR 317.8 and 381.129.
3
required by USDA/FSIS and if applied, would not supercede or replace date
4
marking requirements established by the Food Code or by State/local
5
authorities that apply after the food is opened in a retail establishment.
6
Manufacturer’s use-by dates
7
It is not the intent of
8
beyond that intended by the manufacturer. Manufacturers assign a date to
9
products for various reasons, and spoilage may or may not occur before
10
pathogen growth renders the product unsafe. Most, but not all, sell-by or use-
11
by dates are voluntarily placed on food packages.
12
Although most use-by and sell-by dates are not enforceable by regulators, the
13
manufacturer's use-by date is its recommendation for using the product while
14
its quality is at its best. Although it is a guide for quality, it could be based
15
on food safety reasons. It is recommended that food establishments consider
16
the manufacturer‟s information as good guidance to follow to maintain the
17
quality (taste, smell, and appearance) and salability of the product.
18
product becomes inferior quality-wise due to time in storage, it is possible
19
that safety concerns are not far behind.
20
It is not the intention of this provision that either the manufacturer‟s date or
21
the
22
packages.
23
or
poultry
establishment,
the
information must comply with the
However, such dating is not
this provision to give a product an extended shelf life
If the
date marked by the food establishment be placed on consumer
3-501.19
Using Time as a Public Health Control.*
24
The 2000 Conference for Food Protection (CFP) meeting recommended that FDA
25
ask the National Advisory Committee on Microbiological Criteria for Foods
26
(NACMCF) to review the Food Code provision that addresses using time
27
alone as a public health control, section 3-501.19. In response to the CFP
28
recommendation, FDA in consultation with USDA/FSIS, determined that there
29
is sufficient scientific information available to support the current provision in
30
the Food Code without requesting
consideration by the NACMCF.
Guam Food Code Annex 1 – Public Health Reasons
139
As an
1
alternative response, FDA informed the CFP that it would provide the
2
following position paper on using time alone as a public health control.
3
Position Paper
4
Food
5
(time/temperature control for safety) food that is ready-to-eat (RTE) to be
6
stored without temperature control for up to 4 hours, after which it must be
7
discarded or consumed or for up to 6 hours for refrigerated food, if the food
8
is 5°C (41°F) when initially removed from temperature control, and as long as
9
the food temperature does not exceed 21°C (70°F). The following information is
10
provided to explain the reasoning in allowing time alone to be used as a
11
public health control for food safety.
12
Background information
13
Food kept without temperature control allows product to warm or cool as it
14
equilibrates with the environment. Each temperature scenario incurs different
15
risks in regard to the type of foodborne pathogens able to grow and the rate of
16
growth likely to occur.
17
depends on the amount of time the food spends in an optimum growth temperature
18
range during its equilibration with its surroundings. Several factors influence
19
the rate of temperature change in a food, such as the type of food, thickness
20
of
21
surroundings. When evaluating the safety of a 4-hour limit for food with no
22
temperature control, products and
23
selected to create a worst-case scenario for pathogens growth and possible
24
toxin production.
25
Holding Cold Food Without Temperature Control
26
When a food is removed from refrigerated storage and begins to warm to
27
room temperature, Listeria monocytogenes is a primary organism of concern.
28
Even while food is held at refrigeration temperatures, the growth potential of L.
29
monocytogenes warrants concern for potentially hazardous (time/temperature
30
control for safety foods) RTE foods. Although the FDA and USDA have a
the
Code
food,
section
and
3-501.19
allows
potentially
hazardous food
For both cooling and warming conditions, growth
temperature
differential
between
food and
its
environmental parameters must be
Guam Food Code Annex 1 – Public Health Reasons
140
the
1
zero tolerance for L. monocytogenes in RTE food, conditions are permitted
2
in the Food Code that would allow L. monocytogenes cells 1 log of growth (3.3
3
generations). Salmonella is also a concern especially with products containing
4
eggs. However, L. monocytogenes grows more rapidly than Salmonella at
5
refrigeration and room temperatures. By ensuring minimal Listeria growth in
6
food, the threat from Salmonella would be negligible. Warming conditions will
7
allow food to remain exposed to temperatures that allow B. cereus to
8
produce emetic toxin. However, the 4-hour time constraint in the Food Code is
9
sufficient to prevent any toxin formation.
10
For
food
refrigerated
11
temperature of 75°F for 4 hours, the growth rate of L. monocytogenes remains
12
slow enough to ensure that the critical limit of 1 log growth is not reached.
13
Published generation times at 75°F for L. monocytogenes in food were not
14
found, however published values at 68ºF and 70°F in egg and milk products
15
confirmed slow L. monocytogenes growth at room temperatures.
16
Using the USDA Pathogen Modeling Program (PMP) and assuming the optimum
17
conditions of pH 6.8, 0.5% NaCl, 0.0% nitrite, L. monocytogenes would require
18
more than 4 hours to grow 1 log at 75°F. The PMP is based on broth studies and
19
not on food products. Therefore, the growth rates reported at various
20
temperatures by the PMP are faster than growth rates in most food products.
21
Another factor exaggerating the growth rate in this warming scenario as
22
predicted by the PMP is the assumption that the food product spent all 4
23
hours at 75°F. Obviously food equilibrates with the surrounding environment
24
at a gradual rate and would not equilibrate instantly.
25
Unfortunately there are no models that take changing temperatures into
26
consideration when predicting growth. Likewise there are very few published
27
papers dealing with the growth of organisms in food during warming.
28
conservative nature of the 4-hour limit for keeping foods without temperature
29
control
30
environment is higher than 75°F.
allows
for
at
41ºF
a needed
or
45°F
margin of
then transferred to an ambient
safety if the temperature of the
Guam Food Code Annex 1 – Public Health Reasons
141
The
1
It is important to note that potentially hazardous (time/temperature control for
2
safety) foods held without cold holding temperature control for a period of 4
3
hours do not have any temperature control or monitoring. These foods can
4
reach any temperature when held at ambient air temperatures as long as they
5
are discarded or consumed within the four hours.
6
Holding Hot Food without Temperature Control
7
The second scenario for food without temperature control exists when food is
8
cooked according to Food Code recommendations, then kept at room temperature
9
for 4 hours before discarding.
Foodborne pathogens of concern for
temperature scenario
an
10
uncontrolled
are sporeformers including Clostridium
11
perfringens and Bacillus cereus.
12
guidelines should be free of vegetative cells. However, the heat requirements are
13
not sufficient to kill spores of C. perfringens or B. cereus and may actually
14
serve as a heat shock that activates the spores. B. cereus is found
15
commonly in outbreaks attributed to inadequate hot holding of starchy foods
16
like rice, and has been isolated in a multitude of food products. C.
17
perfringens is found commonly in outbreaks attributed to inadequate hot holding
18
of beef and poultry.
19
perfringens cases are estimated to be more numerous than B. cereus cases by
20
a factor of 10.
21
B. cereus can produce emetic toxin in food, and the optimum temperature
22
for the production of toxin is between 77°F and 86°F. However, the time
23
needed to produce the toxin is longer than the time the food will be exposed
24
to any temperature range with a 4-hour holding limit. Both C. perfringens and
25
B. cereus produce enterotoxin inside the intestine of the infected host if
26
substantial numbers of vegetative cells are present in the food (10 5-7 CFU/g).
27
Although the reported levels of both spores in raw foods vary in the literature,
28
generally the level expected in food can be assumed to be low (around 10-
29
1000 CFU/g).
30
spore could be tolerated in food.
Food cooked according to Food Code
Despite the prevalence of both spores in nature, C.
This implies that conditions allowing 1 log growth of either
Guam Food Code Annex 1 – Public Health Reasons
142
1
During the time without temperature control, the temperature of the food could
2
decrease slowly enough to expose spores of both organisms to optimal growth
3
conditions for a significant length of time. Like warming, several variables exist
4
that determine the rate of heat transfer. Because of the wide variety of foods
5
prepared it would be impossible to generalize how fast a typical product loses
6
temperature after cooking.
7
case scenario where heat loss is slowed. A beef roast slow cooked to 130°F
8
for the appropriate
9
consideration for possible spore growth. Cooking roast beef to 130°F can
10
create an anaerobic environment in both the meat and gravy. The low
11
internal temperature creates
12
environment (assumed
13
food‟s temperature.
14
After evaluating published studies as well as data collected at the FDA, the
15
surface of a roast beef or rolled meat product would lose heat quickly
16
enough to discourage significant growth of either C. perfringens or B.
17
cereus. If all spores were distributed on the surface of the product by either
18
pre- or post-cooking contamination, storing this product for 4 hours at room
19
conditions would be considered safe. Likewise, products that are stirred or
20
products that lose heat faster than a roast would also be considered safe.
21
FDA intends to do research regarding food products that may have spores in
22
the center of the product, and further evaluate if there are potential hazards
23
that may be associated with them while held without temperature control for
24
4 hours.
As with warming, it is prudent to imagine a worst-
time according to
a
the
small
Food
Code
temperature
at 75°F), allowing
was
differential
used
as
with the
for a slower decrease in the
25
----------- End of position paper ---------
26
27
28
At the
2004
meeting of
the
CFP, a
29
Conference accepted a document that examined scientific research related to
30
the growth of Listeria
monocytogenes,
committee submitted and
and
the
Guam Food Code Annex 1 – Public Health Reasons
143
the
influence of time and
1
temperature on its
growth.
The CFP committee report is found at
2
http://www.foodprotect.org/doc/04_issues/folder_attachments/III-008a%finalreport-
3
timeasapublichealthcontrol.pdf.
4
The 2004 CFP report stated that the USDA-PMP program can be used as
5
a tool to estimate time periods for a 1-log increase in growth for Listeria
6
monocytogenes
7
modeling approach, at 41°F, 45°F, and 50°F, the time for a 1-log increase
8
was, 87.8, 53.9, and 34.7 hours, respectively. At room temperature (70°F) a 1-
9
log increase was noted at
in ideal (laboratory media) growth conditions.
Using this
5.2 hours and at ideal growth temperatures
10
(95°F), the reported time for a 1-log increase was 3.0 hours. In general, the
11
data from the USDA-PMP program provides very conservative growth data
12
and, in most cases, growth would be expected to be less rapid in a food
13
system. This table does provide comparative information relative to growth
14
rates at different holding temperatures in the event that time was used as a
15
factor in managing food safely.
16
The report further recommended that food could safely be held for up to
17
6
18
temperature did not exceed 70 F. Based on that report and data from the
19
Quantitative Assessment of the Relative Risk to Public Health from Foodborne
20
Listeria monocytogenes Among Selected Categories of Ready-to-Eat Foods
21
September 2003, the Food Code
22
(time/temperature control for safety) food to be stored up to 6 hours without
23
external temperature control provided that the food temperature does not
24
exceed 70 F and the food is discarded or consumed at the end of the 6
25
hours.
hours
without
external
temperature
control
as long as the food
allows potentially hazardous food
26
Raw eggs
27
Recipes in which more than one egg is combined carry an increased risk of
28
illness and possible serious consequences for certain people. It is due to this
29
increased risk, and documented occurrences of foodborne illness and death
30
among highly susceptible populations from temperature-abused raw shell eggs
Guam Food Code Annex 1 – Public Health Reasons
144
1
contaminated with Salmonella Enteritidis, that the use of time as a public
2
health control in institutional settings is not allowed.
3
Specialized
4
Processing
5
Methods
6
Specific food processes that require a variance have historically resulted in
7
more foodborne illness than standard processes. They present a significant
8
health risk if not conducted under strict operational procedures. These types
9
of operations may require the person in charge and food employees to use
10
specialized equipment and demonstrate specific competencies. The variance
11
requirement is designed to ensure that the proposed method of operation is
12
carried out safely.
13
The concept of variances may be new to some regulatory authorities. Some
14
jurisdictions may not have a formal process to respond to industry requests for
15
variances, although informal allowances may have been allowed in specific
16
situations. Recognizing the opportunity to use the variance process may
17
require additional rulemaking, or at least policy development, at the jurisdictional
18
level. Rulemaking can be used to outline the procedures for a variance
19
request, including the information required in section 8-103.11. In addition, the
20
rulemaking
21
consider an industry‟s variance application and an appeals process in case a
22
variance is not given due consideration or is denied. The Conference for Food
23
Protection Variance Committee recommended that regulatory agencies adopt a
24
variance
25
procedures is given below.
26
Regulatory authorities considering implementing variances have encountered
27
issues relating to their authority or technical, scientific ability to evaluate or
28
validate a variance request. From any variance request there may emerge a
29
set of complex issues and scientific competencies beyond the ability of the
30
regulatory authority to validate. The Conference for Food Protection Variance
3-502.11
Variance Requirement.*
process can address the regulatory
review
process.
General
guidance
authority‟s responsibility to
regarding
Guam Food Code Annex 1 – Public Health Reasons
145
administrative
1
Committee recommended that rulemaking should reflect a multi-level matrix of
2
regulatory agencies ranging from local regulatory authorities through FDA and
3
reflected that recommendation in the following flow chart. The regulatory
4
authority is encouraged to seek input and guidance
5
sources
6
academia. Within the Variance Committee's model, the process for seeking FDA
7
advice begins with the Regional Food Specialists.
8
Except for the Interstate Travel Program, FDA generally does not directly
9
regulate retail
such
as
and
processing
food
authorities,
service
professional
establishments,
from
authoritative
associations,
including
or
entertaining
10
variances for that segment of the industry. FDA is still exploring processes for
11
handling variances on a national basis such as those received from national chain
12
businesses. In conjunction with the 2000 CFP Variance Committee, FDA will
13
continue to explore ways to provide assistance and guidance to regulators
14
regarding access to scientific and technical resources in order to make
15
science-based decisions regarding variances.
16
FDA recommends that regulatory authorities develop a written administrative
17
process that is consistent with, and addresses the information contained in,
18
Food Code sections 8-103.10, 8-103.11, and 8-103.12, and follow a process
19
consistent with the recommendations of the CFP Variance Committee as shown
20
in its flow chart.
Guam Food Code Annex 1 – Public Health Reasons
146
1
3-501.11 Chart 1 – A Model Flow Process for State Regulators to Address Variances
2
Developed by the CFP Variance Committee
3
4
5
6
7
8
Multi-state
issue or
food in
interstate
commerce
FDA
Regional
Food
Specialist
(RFS)
In-state
issue or
intrastate
commerce
Review by
state, local,
or tribal
Regulatory
Authority
(RA)
Referral to
FDA/CFSAN
by RFS, if
needed
FDA makes
recommendation
9
10
11
12
13
14
15
Does RA have
technical
ability to make
a decision?
RA makes
variance
decision
Disseminate
information
to interested
parties
16
17
18
19
Yes
No
20
21
22
23
24
25
26
Disseminate
information
to interested
parties
Notify RFS
of RA
decision
Further
evaluation
required –
refer to
FDA/RFS
27
28
29
30
31
32
Guam Food Code Annex 1 – Public Health Reasons
147
FDA makes
recommendation
1
2
3
Model Administrative Procedures for Regulators to Address Variances
1)
Designate an agency team and assign a leader to address variance requests.
2)
Establish an agency review process leading to approval or denial of variance
4
5
6
applications.
7
consulting with food processing authorities, food scientists, academia,
8
professional organizations, other government agencies including the FDA
9
Regional Food Specialist, or other experts external to the agency.
10
3)
For food safety issues, include recommendations for
Set reasonable timelines for decision making.
Determine of the variance
11
application addresses an intrastate or interstate issue.
12
a)
For variances that have interstate or national implications, especially
13
those that address food safety, regulators are urged to contact and work
14
closely with their FDA Regional Food Specialist to determine if a
15
national policy related to the issue exists. Regulators are encouraged to
16
be consistent with national policies, guidelines, or opinions.
17
b)
For variances that address intrastate issues, regulators are also
18
encouraged to determine if other State or national guidance exists,
19
and to stay consistent with it.
20
4)
21
Make the agency‟s decision. Inform the applicant.
a)
22
document all special provisions with which the applicant must comply.
23
b)
24
25
26
If the variance request is approved, determine the starting date and
If the variance request is denied, inform the applicant as to the reasons
for the denial, the applicant's right to appeal, and the appeal process.
5)
a)
Inform other interested parties, including the FDA Regional Food Specialist.
For variances having interstate or national implications, especially those
27
that address food safety, regulators are urged to inform their FDA
28
Regional
29
appropriately disseminate the information regarding food safety variances
30
that may affect food establishments in other jurisdictions, such as
Food Specialist
so
that
FDA
is
Guam Food Code Annex 1 – Public Health Reasons
148
aware of, and
can
1
national chains.
2
b)
3
4
For variances that address intrastate issues, regulators are encouraged
to share the information as if it were an interstate issue.
6)
Document all agency actions and decisions in the facility‟s file. Consider
5
including documentation of special variance provisions on the establishment's
6
permit to operate.
7
7)
If the variance is approved, inform the inspector assigned to that facility
8
and train the inspector on the variance provisions, including the
9
implementation of the industry‟s HACCP plan, if required.
10
8)
Establish procedures to periodically review the status of the variance,
11
determine if it successfully accomplishes its public health objective, and ensure
12
that a health hazard or nuisance does not result from its implementation.
13
9)
Establish written procedures for withdrawing approval of the variance if it
14
is not successful.
15
3-502.12
Reduced Oxygen Packaging, Criteria.*
16
Reduced oxygen packaging (ROP) encompasses a large variety of packaging
17
methods where the internal environment of the package contains less than the
18
normal ambient oxygen level (typically 21% at sea level), including vacuum
19
packaging (VP), modified atmosphere packaging (MAP), controlled atmosphere
20
packaging (CAP), cook chill processing (CC), and sous vide (SV). Using ROP
21
methods in food establishments has the advantage of providing extended
22
shelf life to many foods because it inhibits spoilage organisms that are
23
typically aerobic.
24
This state of reduced oxygen is achieved in different ways. Oxygen can be
25
withdrawn from the package (VP) with or without having another gas such as
26
nitrogen or carbon dioxide replacing it (MAP). Fresh produce and raw meat or
27
poultry continue to respire and use oxygen after they are packaged. Bacterial
28
activity also plays a role here.
29
transmission of oxygen is usually designated by an Oxygen Transfer Rate of
30
10,000 cm2/m3/24 hours or greater. A reduced oxygen atmosphere will result with
Packaging material that readily allow the
Guam Food Code Annex 1 – Public Health Reasons
149
1
an Oxygen Transmission rate of 10-100. The process of cooking drives off
2
oxygen (the bubbling is oxygen gas coming off) and leaves a reduced oxygen
3
level in the food, thus, microenvironments of reduced oxygen are possible
4
even without packaging that has a barrier to oxygen transmission.
5
Most foodborne pathogens are anaerobes or facultative anaerobes able to
6
multiply under either aerobic or anaerobic conditions, therefore special
7
controls are
8
temperatures of 5°C (41°F) may be adequate to prevent growth and/or toxin
9
production of some pathogenic microorganisms but non-proteolytic C. botulinum
10
and L. monocytogenes are able to multiply well below 5°C (41°F). For this
11
reason, C. botulinum and L. monocytogenes become the pathogens of
12
concern for ROP.
13
foodborne pathogens as well.
14
The control of C. botulinum or L. monocytogenes when using ROP is
15
usually accomplished using multiple hurdles or barriers to growth. Subparagraph
16
3-502.12(B)(2) identifies secondary barriers that will control the growth of C.
17
botulinum
18
storage temperature of 5°C (41°F) or less. They include aw of 0.91 or less; pH
19
of 4.6 or
20
substances
21
microorganisms. C. botulinum will not produce toxin below an aw of 0.91.
22
Nitrite, used in meat and poultry curing, inhibits the outgrowth of C. botulinum
23
spores.
24
microorganisms, therefore foods that have a high level of spoilage organisms
25
or lactic acid bacteria can safely be packaged using ROP.
26
Naturally fermented cheeses, as identified in ¶ 3-502.12(E), that meet the
27
Standards of Identity for hard, pasteurized process, and semisoft cheeses in 21
28
CFR 133.150, 21 CFR 133.169, or 21 CFR 133.187, respectively, contain
29
various
30
secondary
necessary
to
control
their
growth.
Refrigerated
storage
Controlling their growth will control the growth of other
and L. monocytogenes when used in conjunction with a food
less;
cured,
USDA inspected
meat or poultry products using
specified in 9 CFR 424.21;
Most foodborne pathogens do not
or high levels of competing
compete well with other
intrinsic factors, often acting synergistically, that together act as a
barrier to pathogen growth along with refrigerated storage at 5°C
Guam Food Code Annex 1 – Public Health Reasons
150
1
(41°F) or less. This combination of factors could include some or all of the
2
following: a lower pH, production of organic acids, and natural antibiotics or
3
bacteriocins such as nisin by lactic acid bacteria, salt (NaCl) added during
4
processing, low moisture content,
5
cultures. Very few outbreaks have occurred that were associated with cheese.
6
The few outbreaks of foodborne illness
7
products could be traced in large part to temperature abuse with storage at
8
uncontrolled ambient air temperatures.
9
packaged under ROP include Asiago medium, Asiago old, Cheddar, Colby,
10
Emmentaler, Gruyere, Parmesan, Reggiano, Romano, Sapsago, Swiss, pasteurized
11
process cheese, Asiago fresh and soft, Blue, Brick, Edam, Gorgonzola, Gouda,
12
Limburger, Monterey, Monterey Jack, Muenster, Provolone, and Roquefort. Soft
13
cheeses such as Brie, Camembert, Cottage, and Ricotta may not be packaged
14
under reduced oxygen because of their ability to support the growth of L.
15
monocytogenes under modified atmosphere conditions.
16
When the food to be packaged under reduced oxygen conditions cannot
17
reliably depend on secondary barriers such as aw, pH, nitrite in cured meat
18
products, high levels of competing microorganisms or intrinsic factors in certain
19
cheeses, time/temperature becomes the critical controlling factor for growth of
20
C. botulinum and L. monocytogenes. In ¶ 3-502.12(D), cook-chill processing
21
where food is cooked then sealed in a barrier bag while still hot and sous vide
22
processing where food is sealed in a barrier bag and then cooked, both
23
depend on time/temperature alone as the only barrier to pathogenic growth.
24
Therefore, monitoring critical limits including those established for cooking to
25
destroy
26
production, and maintaining cold storage temperatures of 1°C (34°F) or less to
27
inhibit growth and/or toxin production of any surviving pathogens is essential.
28
Since there
29
monocytogenes in a cook-chill or sous vide packaging system, temperature
30
control must be continuously monitored electronically and visually examined
vegetative
are
cells,
no
added preservatives, and live competing
cooling
to
other controlling
associated with cheeses or cheese
Examples of cheeses that may be
prevent
factors
outgrowth of spores/toxin
for C. botulinum and L.
Guam Food Code Annex 1 – Public Health Reasons
151
1
twice daily to verify that refrigeration temperatures are adequate.
2
New technology makes it relatively easy to continuously and electronically
3
monitor temperatures of refrigeration equipment used to hold cook chill and
4
sous vide products at 1°C (34°F) or less. Thermocouple data loggers can
5
connect directly with commonly available thermocouple probes. Recording
6
charts are also commonly used. Temperature monitors and alarm systems will
7
activate an alarm or dialer if temperatures rise above preset limits. Nickel-
8
sized data loggers are available to record temperatures which can be displayed
9
using computer software. Since surveys have shown that temperature control
10
in home kitchens is not always adequate, food packaged using cook chill or
11
sous vide processing methods cannot be distributed outside the control of the
12
food establishment doing the packaging.
13
Time is also a factor that must be considered in ROP. The 14 day “use by”
14
date is required label information for VP, MAP, and CAP products and cannot
15
exceed the manufacturer‟s “sell by” or “use by” date.
16
safe time period because two barriers to growth are required to be present.
17
When these ROP products are frozen, there is no longer a restricted 14 day
18
shelf life. The 30 day shelf life for cook chill and sous vide is based on killing
19
all vegetative cells in the cooking process, preventing recontamination, and
20
then refrigerating at 34°F or less with stringent temperature monitoring and
21
recording requirements. These criteria allow both institutional-sized cook chill
22
operations that may feed thousands daily, often including transportation to
23
their satellite locations, and individual restaurants without ice banks and
24
tumble or blast chillers to safely use cook chill processes.
25
The extended shelf life for vacuum packaged hard and semisoft cheeses is
26
based on many intrinsic factors in these cheeses plus the normal refrigeration
27
temperature of 41°F or less to maintain safety.
28
A Hazard Analysis Critical Control Point (HACCP) plan is essential when using
29
ROP processing procedures.
30
potential hazards which must be controlled in most foods unless the food is a low
C. botulinum
and
L. monocytogenes
Guam Food Code Annex 1 – Public Health Reasons
152
This is considered a
are
1
acid canned food produced under 21 CFR Part 108 or 113 or an acidified food
2
produced under 21 CFR 114. Critical control points, critical limits, monitoring,
3
record keeping, corrective actions, and verification procedures will vary based
4
on the type of food and type of ROP technology used.
5
When a food establishment intends to use ROP technology but does not
6
use one of the secondary barriers defined in section 3-502.12 (a single barrier
7
of 34°F combined with the criteria specified in paragraph 3-502.12(D), or
8
hard or semisoft cheeses manufactured using Standards of Identity for those
9
cheeses), the operator must submit an application for a variance under 3-
10
502.11 providing evidence that the ROP methodology intended for use is
11
safe.
12
Unfrozen raw fish and other seafood are specifically excluded from ROP
13
because of these products‟ natural association with C. botulinum type E which
14
grows at or above 3oC (37-38oF). Fish and seafood that are frozen before,
15
during and after the ROP packaging process are allowed.
16
Accurate
3-601.11
Standards of Identity.
17
Representation
3-601.12
Honestly Presented.
18
Labeling
3-602.11
Food Labels.
3-602.12
Other Forms of Information.
19
20
The identity of a food in terms of origin and composition is important for
21
instances
22
nutritional information requirements.
23
consumers who have allergies to certain food or ingredients. The appearance
24
of a food should not be altered or disguised because it is a cue to the
25
consumer of the food's identity and condition.
26
Recent illnesses and deaths from Shiga toxin-producing Escherichia coli have
27
occurred across the United States as a result of people eating hamburgers
28
that were contaminated and then undercooked. USDA issued final rules on
29
August 8, 1994 requiring all raw meat or poultry products have a safe-
when a food may be implicated in a foodborne illness
Ingredient information is needed by
Guam Food Code Annex 1 – Public Health Reasons
153
and for
1
handling label or
2
information on proper handling and cooking procedures.
3
Certain requirements in the CFR relating to aspects of nutrition labeling
4
became effective in May, 1997. The following attempts to provide guidance
5
regarding those requirements and exemptions as they relate to the retail
6
environment and to alert regulators to authority that has been given to them
7
by the Nutrition Labeling and Education Act (NLEA) of 1990. The statute
8
and the CFR should be reviewed to ensure a comprehensive understanding of
9
the labeling requirements.
10
I.
sticker or be accompanied by a leaflet that contains
The following foods need not comply with nutrition labeling in the
11
CFR referenced in subparagraph 3-602.11(B)(5) if they do not bear
12
a nutrient claim, health claim, or other nutrition information:
13
(A)
14
Foods packaged in a food establishment if:
(1)
The food establishment has total annual sales to consumers
15
of no more than $500,000 (or no more than $50,000 in
16
food sales alone), and
17
(2)
The label of the food does not bear a reference to the
18
manufacturer
19
establishment;
20
(B)
21
or
processor
other
than
the
food
Low-volume food products if:
(1)
The annual sales are less than 100,000 units for which a
22
notification claiming exemption has been filed with FDA's
23
Office
24
Supplements Food Labeling by a small business with less
25
than 100 full-time equivalent employees, or
26
(2)
27
28
of
Nutritional
Products
Labeling
and
Dietary
The annual sales are less than 10,000 units by a small
business with less than 10 full-time equivalent employees;
(C)
Foods served in food establishments with facilities for immediate
29
consumption such as restaurants, cafeterias, and mobile food
30
establishments, and foods sold only in those establishments;
Guam Food Code Annex 1 – Public Health Reasons
154
1
(D)
Foods similar to those specified in the preceding bullet but that
2
are sold by food establishments without facilities for immediate
3
consumption such as bakeries and grocery stores if the food is:
4
(1)
5
Ready-to-eat
but
not
necessarily
for immediate
consumption,
6
(2)
7
Prepared primarily in the food establishment from which it
is sold, and
8
(3)
Not offered for sale outside the food establishment;
9
(E)
Foods of no nutritional significance such as coffee;
10
(F)
Bulk food for further manufacturing or repacking; and
11
(G)
Raw fruits, vegetables, and fish.
12
II.
Game animal meats shall provide nutrition information which
13
may be provided by labeling displayed at the point of purchase
14
such as on a counter card, sign, tag affixed to the food, or some
15
other appropriate device.
16
III.
Food packaged in a food processing plant or another food
17
establishment, shall meet the requirements specified in § 3-602.11
18
and enforcement by the regulatory authority is authorized in the
19
NLEA, Section 4. State Enforcement.
20
In 1998,
21
CFR
Part
73, Section 73.75
was
amended to address
21
canthaxanthin
22
Regulatory Fish Encyclopedia, the family Salmonidae includes pink salmon,
23
coho salmon, sockeye salmon, chinook salmon,
24
salmon, rainbow trout, cutthroat trout, and brown trout. This color additive
25
may be in the feed that is fed to aquacultured fish, and when those fish are
26
placed into a bulk container for shipment, the bulk container must bear a label
27
declaring the presence of canthaxanthin. That same label information must be
28
displayed at retail when those fish are offered for sale.
29
The 21 CFR Section 73.75(d)(4) requires that
30
additive in salmonid fish that have been fed feeds containing canthaxanthin be
as a color additive for salmonid fish. According to the FDA
Atlantic salmon, chum
the presence of the color
Guam Food Code Annex 1 – Public Health Reasons
155
1
declared
in
accordance
2
101.100(a)(2).
3
announcement 63 FR 14814, March 27, 1998, Listing of Color Additives
4
Exempt from Certification; Canthaxanthin.
5
On August 2, 2004, President Bush signed into law the Food Allergen Labeling
6
and Consumer Protection Act of 2004 (Public Law 108-282). This new law
7
amended Sections 201 and 403 of the Federal Food, Drug, and Cosmetic Act
8
to establish food allergen labeling requirements for all packaged foods
9
regulated by FDA. The new provisions require that all affected packages of
For
with 21 CFR
additional
101.22(b), (c),
information, see
and
the Federal Register
10
food labeled on or after January 1, 2006
11
names of the food sources of any major food allergens (i.e., the following eight
12
foods and any protein derived from them: milk, egg, fish, crustacean shellfish,
13
tree nuts, wheat, peanuts, and soybeans) used as ingredients in the food.
14
The names of the food sources are the same as the names of the eight
15
foods that are major food allergens, with the exception that for fish,
16
crustacean shellfish, and tree nuts, their respective food source names are
17
the specific species of fish (e.g., bass, flounder, or cod), the specific species
18
of crustacean shellfish (e.g., crab, lobster, or shrimp), and the specific types of
19
tree nuts (e.g., almonds, pecans, or walnuts).
20
Consumer
21
Advisory
22
Refer to the public health reason for § 3-401.11.
23
Purpose:
24
At issue is the role of government agencies, the regulated industry, and others
25
in providing notice to consumers that animal-derived foods that are not
26
subjected to adequate heat treatment pose a risk because they may contain
27
biological agents that cause foodborne disease. The deliverance of a
28
balanced message that communicates fairly to all consumers and, where
29
epidemiologically supported, attempts to place risk in perspective based on
30
the consumer's health status and
3-603.11
must
and (k)(2)
identify on the label the
Consumption of Raw or Undercooked Animal
Foods.*
the food being consumed is part of the
Guam Food Code Annex 1 – Public Health Reasons
156
1
challenge. Notification of risk must be achieved via a meaningful message
2
and in a manner that is likely to affect behavior. The following information is to
3
alert the reader to the options available to food establishments in advising
4
consumers of the increased possibility of foodborne illness when animal-
5
derived foods are eaten raw or undercooked.
6
Background:
7
Although no specific advisory language was recommended, beginning with the
8
1993 Food Code, FDA included a codified provision for a point-of-purchase
9
consumer advisory and stated in Annex 3:
10
“FDA has requested comments and will consider the responses as well
11
as other information that is available related to the risks involved and
12
methods of risk communication to determine what action may be necessary by
13
FDA to effectively inform consumers.”
14
Consumer Focus Groups:
15
During 1996 - 1998, FDA conducted two different consumer focus group
16
studies.
17
Code)
18
Conference for Food Protection (CFP) meeting, that language was not
19
included in the 1997 Code.
20
convened a second set of focus groups with a modified approach. The latter
21
set expressed similar thoughts as those in the earlier set and a pattern for
22
consumer acceptance and receptiveness to menu-based advisories emerged.
23
It became apparent that there is a general appreciation for “disclosure” of what
24
consumers view as “hidden ingredients,” for example, whether a particular
25
menu item contains raw egg. In addition to disclosure being viewed as helpful,
26
consumers
27
consuming raw or undercooked animal-derived foods carries an increased risk
28
of foodborne illness. In the food establishment venue, consumers are less
29
willing to accept a message that extends beyond a reminder and becomes a
30
lesson or an educational message.
Because the first set of focus groups (conducted before the 1997
were not receptive
are
accepting,
to
the
language
recommended at
the 1996
Before the 1998 CFP meeting, the Agency
if not appreciative, of a “reminder” that
Guam Food Code Annex 1 – Public Health Reasons
157
1
Satisfactory Compliance:
2
FDA submitted to the 1998 CFP meeting an Issue that asked the
3
Conference to discuss an approach that incorporated the knowledge obtained
4
from
5
satisfactory compliance with the Code’s consumer advisory provision is
6
fulfilled when both a disclosure and reminder are provided, as described in §
7
3-603.11 of the Code.
8
identification
9
undercooked, and of items that either contain or may contain (to allow for
10
ingredient substitution) such raw or undercooked ingredients. A third option
11
for the consumer “reminder” was added later. The reminder is a notice
12
about the relationship between thorough cooking and food safety.
13
Two options were endorsed for disclosure and two for the reminder. One of
14
the reminder options is a menu statement that advises consumers that food
15
safety information about the disclosed items is available upon request.
16
Essential
17
downloadable
brochure,
on
18
http://www.cfsan.fda.gov/~fc99guid.html.
All
19
essential criteria. The other option is a short notice alerting consumers to the
20
increased risk of consuming the disclosed menu items.
21
In
22
Conference (ISSC) in an October 8, 1998 letter to FDA, a third option has
23
been added to allow for a statement that links an increased risk of illness to
24
consumption of raw or undercooked animal foods by persons with certain
25
medical conditions.
26
The information contained in both the disclosure and reminder should be
27
publicly available and readable so that
28
message (disclosure and reminder) before making their order selections.
29
It is not possible to anticipate all conceivable situations. Therefore, there will
30
always
the
consumer
of
testing.
animal-derived
be
model
to
was
Disclosure
criteria for such
response
It
concerns
is
foods
written
raised
the
consensus of the CFP that
achieved
when
that
sold or served raw or
are
information
by
the
are
must
clear
with
website
meet
a
at
these
Interstate Shellfish Sanitation
consumers have benefit of the total
need for discussion between
the food establishment and the
Guam Food Code Annex 1 – Public Health Reasons
158
is
available,
CFSAN
brochures
the
there
1
Regulatory Authority as to the most effective way to meet the objectives of
2
satisfactory compliance.
3
The Implementation Guidance for the Consumer Advisory Provision of the FDA
4
Food Code (section 3-603.11 in the FDA Model Food Code), is a resource
5
intended to assist regulators and industry in the implementation of the
6
Consumer Advisory provision. It is recommended that it be used in
7
conjunction with the FDA Food Code. It is available on the FDA/CFSAN
8
website at http://www.cfsan.fda.gov/~dms/fc99guid.html.
9
Locating the Advisory:
10
Disclosure of raw or undercooked animal-derived foods or ingredients and
11
reminders about the risk of consuming such foods belong at the point where
12
the food is selected by the consumer. Both the disclosure and the reminder
13
need to accompany the information from which the consumer makes a selection.
14
That information could appear in many forms such as a menu, a placarded listing
15
of available choices, or a table tent.
16
Educational Messages:
17
Educational messages are usually longer, more didactic in nature, and
18
targeted to consumers who have been alerted to the food safety concern and
19
take the initiative to obtain more detailed information. It is expected that, in
20
most cases, educational messages that are provided pursuant to § 3-603.11
21
(i.e., in situations where the option for referring the consumer to additional
22
information is chosen), will be embodied in brochures that will not be read at
23
the site where the immediate food choice is being made. Nonetheless, such
24
messages are viewed as an important facet of arming consumers with the
25
information needed to make informed decisions and, because the information is
26
being requested by the consumer, it
27
subsequent choices.
28
Applicability:
29
Food Establishments:
would
be expected to play a role in
Guam Food Code Annex 1 – Public Health Reasons
159
1
The consumer advisory is intended to apply to all food establishments where
2
raw or undercooked animal foods or ingredients are sold or served for human
3
consumption in a raw or undercooked form. This includes all types of food
4
establishments whenever there is a reasonable likelihood that the food will be
5
consumed without subsequent, thorough cooking - such
6
bars, quick-service operations, carry-outs, and sites where groceries are
7
obtained that have operations such as delicatessens or seafood departments.
8
9
as restaurants, raw
“...Otherwise Processed to Eliminate Pathogens...”:
This phrase is included in
§ 3-603.11 to encompass new technologies and
10
pathogen control/reduction regimens as they are developed and validated as
11
fulfilling
12
Pasteurization of milk is an example of a long-standing validated process. For
13
purposes of the Food Code, the level of pathogen reduction that is required
14
before a raw or undercooked animal food is allowed to be offered without a
15
consumer advisory must be equivalent to the levels provided by § 3-401.11 for
16
the type of food being prepared.
17
The absorbed dose levels of radiation approved by FDA on December 3,
18
1997 for red meat are insufficient to reduce the level of most vegetative
19
pathogens to a point that is equivalent to the reductions achieved in ¶¶ 3-
20
401.11(A) and (B). Irradiated poultry provides a 3D kill which does not
21
provide the level of
22
regimen in the Food Code. Therefore, irradiated meat and poultry are not
23
allowed to be offered in a ready-to-eat form without a consumer advisory. It is
24
intended that future Food Code revisions will
25
requirements that take into consideration the pathogen reduction that occurs
26
with irradiated foods.
27
Recognition of Other Processes:
28
Animal-derived foods may undergo validated processes that target a specific
29
pathogen. In such instances, along with the required consumer advisory may
30
appear additional language that accurately describes the process and what it
a
specific performance
standard
for pathogens of concern.
protection of the 7D kill that results from the cooking
address time/temperature
Guam Food Code Annex 1 – Public Health Reasons
160
1
achieves. For example, a technology for reducing Vibrio vulnificus in oysters
2
to nondetectable levels has been validated.
3
subjected
4
appropriately describes the product. That is, a statement could be made
5
such as, “pasteurized to reduce Vibrio vulnificus” or “temperature treated to
6
reduce Vibrio vulnificus.” Such a claim must be in accordance with labeling
7
laws and regulations, accurate, and not misleading.
8
however, negate the need for a consumer advisory because the treatment
9
only reduces the level of one pathogenic organism.
to
that process can be
labeled
FDA concurs that shellfish
with
a
truthful
claim
that
The claim would not,
10
Product-specific Advisories:
11
Consumer advisories
12
establishment either has a limited menu or offers only certain animal-derived
13
foods in a raw or undercooked ready-to-eat form. For example, a raw bar
14
serving molluscan shellfish on the half shell, but no other raw or undercooked
15
animal food, could elect to confine its consumer advisory to shellfish. The raw
16
bar could also choose reminder, option #3, which would highlight the
17
increased risk incurred when persons with certain medical conditions ingest
18
shellfish that has not been adequately heat treated.
19
Terminology:
20
It should be noted that the actual on-site (e.g., on-the-menu) advisory
21
language differs from the language in the codified provision, § 3-603.11. In the
22
insert page for § 3-603.11, the Reminder options 2 and 3 use terms for
23
foods that are less specific than the terms used in the actual code section.
24
That is, the words “meat” rather than “beef, lamb, and pork” and “seafood”
25
rather than “fish” are used. Categorical terms like “meat” are simpler and
26
may be more likely used in conversation, making them suitable for purposes
27
of a menu notice.
may
be tailored
to be product-specific if a food
Guam Food Code Annex 1 – Public Health Reasons
161
1
Milk:
2
In addition, “milk” is not mentioned in the actual on-site advisory language.
3
The sale or transportation of final packaged form of unpasteurized milk into
4
interstate commerce is specifically prohibited by 21 CFR 1240.61. Also the
5
consumption of raw milk is not recommended by FDA (this statement is in
6
the
7
http://www.cfsan.fda.gov/~ear/mi-03-4.html. Nonetheless, approximately 27 states
8
allow unpasteurized milk in intrastate commerce which usually involves direct
9
dairy farm-to-consumer procurement.
form
of
an
official
FDA
position
statement
found
at
10
In the event that a food establishment governed by § 3-603.11 of this Code
11
operates in conjunction with a dairy farm in a State that allows the in-State sale
12
or
13
unpasteurized
14
consumers
15
unpasteurized milk. In these situations, the actual advisory language needs to
16
be amended to include milk (refer to Consumer Advisory Reminder, paragraph
17
3-603.11(C), options 2 or 3).
18
Molluscan Shellstock:
19
In addition to areas of retail food stores such as delis in supermarkets, the
20
consumer advisory is to be provided when a seafood department or seafood
21
market offers raw molluscan shellstock for sale or service. There is a risk of
22
death from Vibrio infections from consuming raw molluscan shellstock for
23
persons who have certain medical conditions.
24
Disposition
25
service
of unpasteurized
milk
need
to
to
milk, or in the case where a State allows
be marketed
be
3-701.11
advised
via retail-level food establishments,
of
the risk associated with drinking
Discarding or Reconditioning Unsafe,
Adulterated, or Contaminated Food.*
26
Pathogens may be transmitted from person to person through contaminated
27
food. The potential l spread of illness is limited when food is discarded if it
28
may have been contaminated by employees who are infected, or are
29
suspected of being infected, or by any person who otherwise contaminates it.
Guam Food Code Annex 1 – Public Health Reasons
162
3-801.11
Pasteurized Foods, Prohibited Re-Service,
1
Additional
2
Safeguards
3
Refer to the public health reason for § 3-201.11.
4
The Code provisions that relate to highly susceptible populations are
5
combined in this section for ease of reference and to add emphasis to
6
special food safety precautions that are necessary to protect those who are
7
particularly vulnerable to foodborne illness and for whom the implications of
8
such illness can be dire.
9
As a safeguard for highly susceptible populations from the risk of contracting
10
foodborne illness from juice, prepackaged juice is required to be obtained
11
pasteurized or in a commercially sterile, shelf-stable form in a hermetically
12
sealed container. It is important to note that the definition of a “juice” means
13
it is served as such or used as an ingredient in beverages. Puréed fruits and
14
vegetables,
15
susceptible populations, are not juices and do not require HACCP plans or
16
compliance with 21 CFR Part 120.
17
foodborne illness throughout the United States that were associated with the
18
consumption of various juice products contaminated with microorganisms such
19
as Cryptosporidium, Shiga toxin-producing Escherichia
20
spp., and Vibrio cholera. As new information becomes available, the Food
21
Code will be modified or interim interpretive guidance will be issued regarding
22
foodborne illness interventions for on-site juicing and puréeing.
23
The 21 CFR 120 regulation applies to products sold as juice or used as an
24
ingredient in beverages. This includes fruit and vegetable purées that are
25
used in juices and beverages, but is not intended to include freshly prepared
26
fruit or vegetable purées that are prepared on-site in a facility for service to
27
a highly susceptible population.
28
In lieu of meeting the requirements of 21 CFR 120, juices that are produced
29
as commercially sterile products (canned juices) are acceptable for service to a
30
highly susceptible population.
and Prohibited Food.*
which
are
commonly prepared as food for service to highly
There are
documented cases of
Persons providing puréed
Guam Food Code Annex 1 – Public Health Reasons
163
coli, Salmonella
meals to highly
1
susceptible populations may also wish to use
2
produced as commercially sterile products (canned fruit or vegetables) as a
3
means of enhancing food safety.
4
Salmonella often survives traditional preparation techniques. It survives in a
5
lightly cooked omelet, French toast, stuffed pasta, and meringue pies. In 1986
6
there was a large multistate outbreak of Salmonella Enteritidis traced to
7
stuffed pasta
8
major
9
combined and undercooked as was the case in the 1986 outbreak linked to
10
stuffed pasta. Therefore, special added precautions need to be in place with
11
those most susceptible to foodborne illness.
12
Operators of food establishments serving highly susceptible populations may
13
wish to discuss buyer specifications with their suppliers. Such specifications
14
could stipulate eggs that are produced
15
Salmonella Enteritidis control program that is recognized by a regulatory
16
agency that has animal health jurisdiction. Such programs are designed to
17
reduce the presence of Salmonella Enteritidis in raw shell eggs. In any
18
case, the food establishment operator must use adequate time and temperature
19
controls within the establishment to minimize the risk of a foodborne illness
20
outbreak relating to Salmonella Enteritidis.
21
Since
22
foodborne illness in the United States. The FDA and CDC have issued health
23
advisories that persons who are at a greater risk for foodborne disease should
24
avoid eating raw alfalfa sprouts until such time as intervention methods are in
25
place to improve the safety of these products. Further information is available
26
at the FDA website, http://www.fda.gov, by entering “sprouts” in the search
27
window.
28
Although the Code‟s allowance for the Regulatory Authority to grant a variance
29
(refer to §§ 8-103.10 - .12, 8-201.14, and 8-304.11) is applicable to all Code
30
provisions, variance requests related to the preparation of food for highly
source
fruit and vegetables that are
made with raw eggs and labeled “fully cooked.” Eggs remain a
of these infections, causing
large outbreaks when they are
only
by flocks managed under a
1995, raw seed sprouts have emerged as a recognized source of
Guam Food Code Annex 1 – Public Health Reasons
164
1
susceptible populations must be considered with particular caution and
2
scrutiny. With all variances, the hazard(s) must be clearly identified and
3
controlled by a HACCP plan that is instituted in conjunction with a standard
4
operating plan that implements good retail practices. Variances that will impact
5
a highly susceptible population must be considered in light of the fact that
6
such a population is at a significantly higher risk of contracting foodborne
7
illnesses and suffering
8
illnesses, than is the general population.
9
Subparagraph 3-801.11(F)(3) requires a HACCP plan for the use of raw shell
when
eggs
are
serious consequences
combined
in
food
including
death from those
10
eggs
establishments serving highly
11
susceptible populations.
12
criteria are specific, prescriptive, and conservative and require a cooking
13
temperature and time to ensure destruction of Salmonella Enteritidis.
A variance is not required since the HACCP plan
3-801.11(G) and (H) Re-service of food
14
15
The Food Code addresses two issues concerning persons in isolation:
16
1.
17
The re-service of any food including unopened, original, intact packages in
18
sound condition, of non-potentially hazardous food (temperature controlled for
19
safety) from a person in isolation or quarantine for use by anyone else (other
20
patients, clients, or consumers) is not permitted. The “isolation or quarantine”
21
terminology in the Code text refers to a patient-care setting that isolates the
22
patient, thereby preventing spread of key pathogens to other patients and
23
healthcare workers. Once food packages come to a contact isolation room, they
24
stay there until the patient uses or discards them. If packages of food are
25
still in the room when the patient is discharged or moved from isolation,
26
they must be discarded.
27
2.
28
environment” isolation setting which protects the patient from contacting
29
pathogens from other patients, healthcare workers, or other persons.
30
Packages of food from any patients, clients or other consumers should not be
Contamination from an isolated patient to others outside.
Contamination from the outside into a room with a patient in a “protective
Guam Food Code Annex 1 – Public Health Reasons
165
1
re-served to persons in protective environment isolation. Precautions similar to
2
the
3
intact package of condiment is delivered to this patient, the package stays there
4
until used or discarded. New (not re-served)
5
delivered to this patient each time.
6
To summarize the key difference between the two scenarios:
isolation setting apply to this setting, i.e., once an unopened, original,
packages of food should
be
7
Food packages served to patients in contact isolation may not be
8
re-served to other patients because of the potential for disease
9
transmission to other patients.
10
Patients in protective environments should not be re-served with
11
food packages from other patients because of the potential for
12
disease transmission to the protective environment patient.
Chapter 4 Equipment, Utensils, and Linens
13
4-101.11
Characteristics.*
14
Multiuse
15
Multiuse equipment is subject to deterioration because of its nature, i.e.,
16
intended use over an
17
harmful chemicals to be transferred to the food being prepared which could
18
lead to foodborne illness. In addition, some materials can affect the taste of the
19
food being prepared. Surfaces that are unable to be routinely cleaned and
20
sanitized because of the materials used could harbor foodborne pathogens.
21
Deterioration of the surfaces of equipment such as pitting may inhibit
22
adequate cleaning of the surfaces of equipment, so that food prepared on or in
23
the equipment becomes contaminated.
24
Inability to effectively wash, rinse
25
equipment
26
through food. Studies regarding the rigor required to remove biofilms from
27
smooth surfaces highlight the need for materials of optimal quality in multiuse
28
equipment.
29
30
extended period of time. Certain materials allow
and sanitize the surfaces of food
may lead to the buildup of pathogenic organisms transmissible
4-101.12
Cast Iron, Use Limitation.
Equipment and utensils constructed of cast iron meet the requirement of
Guam Food Code Annex 1 – Public Health Reasons
166
1
durability
as
intended
in section
2
characteristics of cast iron tend to be somewhat porous which renders the material
3
difficult to clean. On the other hand, when cast iron use is limited to cooking
4
surfaces the residues in the porous surface are not of significant concern as
5
heat destroys potential pathogens that may be present.
4-101.13
6
4-101.11.
However,
the
surface
Lead, Use Limitation.
7
Historically, lead has been used in the formulation or decoration of these
8
types of utensils. Specifically, lead-based paints that were used to decorate
9
the utensils such as color glazes have caused high concentrations of lead to
10
leach into the food they contain.
11
Lead poisoning continues to be an important public health concern due to the
12
seriousness of associated medical problems.
13
harmful to the young and has caused learning disabilities and medical
14
problems among individuals who have consumed high levels. The allowable
15
levels of lead are specific to the type of utensil, based on the average contact
16
time and properties of the foods routinely stored in each item listed.
17
FDA has established maximum levels (see FDA Compliance Policy Guide
18
Section
19
Contamination (CPG 7117.07) for leachable lead in ceramicware, and pieces that
20
exceed these levels are subject to recall or other agency enforcement action.
21
The levels are based on how frequently a piece of ceramicware is used, the
22
type and temperature of the food it holds, and how long the food stays in
23
contact with the piece. For example, cups, mugs, and pitchers have the most
24
stringent action level, 0.5 parts per million, because they can be expected to
25
hold food longer, allowing more time for lead to leach. Also, a pitcher may be
26
used to hold fruit juice. And a coffee mug is generally used every day to
27
hold a hot acidic beverage, often several times a day.
28
The FDA allows use of lead glazes because they‟re the most durable, but
29
regulates them tightly to ensure their safety. Commercial manufacturers employ
30
extremely strict and effective manufacturing controls that keep the lead from
545.450 Pottery (Ceramics);
Lead poisoning is particularly
Imported and Domestic – Lead
Guam Food Code Annex 1 – Public Health Reasons
167
1
leaching during use. Small potters often can‟t control the firing of lead glazes
2
as well so their ceramics are more likely to leach illegal lead levels, although
3
many do use lead-free glazes.
4
In 21 CFR 109.16, FDA requires high-lead-leaching decorative ceramicware
5
to be permanently labeled that it‟s not for food use and may poison food.
6
Such items bought outside the United States may not be so labeled,
7
potentially posing serious risk if used for food.
8
Pewter refers to a number of silver-gray alloys of tin containing various
9
amounts of antimony, copper, and lead.
The same concerns about the
10
leaching of heavy metals and lead that apply to brass, galvanized metals,
11
copper, cast iron, ceramics, and crystal also apply to pewter. As previously
12
stated, the storage of acidic moist foods in pewter containers could result in
13
food poisoning (heavy metal poisoning).
14
Solder is a material that is used to join metallic parts and is applied in the
15
melted state to solid metals. Solder may be composed of tin and lead alloys.
4-101.14
16
Copper, Use Limitation.*
17
High concentrations of
18
illness. When copper and copper alloy surfaces contact acidic foods, copper may
19
be leached into the food. Carbon dioxide may be released into a water supply
20
because of an ineffective or nonexistent backflow prevention device between a
21
carbonator and copper plumbing components. The acid that results from
22
mixing
23
components and the leachate is then transferred to beverages, causing copper
24
poisoning.
25
alloys can cause, and have resulted in, the leaching of both copper and lead into
26
carbonated beverages.
27
Brass is an alloy of copper and zinc and contains lead which is used to
28
combine the two elements. Historically, brass has been used for items such
29
as pumps, pipe fitting, and goblets.
water
and
copper are poisonous and have caused foodborne
carbon
dioxide
leaches
copper from
the plumbing
Backflow prevention devices constructed of copper and copper
All 3 constituents are subject to leaching
Guam Food Code Annex 1 – Public Health Reasons
168
1
when they contact acidic foods, and food poisoning has resulted from such
2
contact.
3
The steps in beer brewing include malting, mashing, fermentation, separation of
4
the alcoholic beverage from the mash, and rectification. During mashing, it is
5
essential to lower the pH from its normal 5.8 in order to optimize enzymatic
6
activity. The pH is commonly lowered to 5.1-5.2, but may be adjusted to as low
7
as 3.2. The soluble extract of the mash (wort) is boiled with hops for 1 to 22
8
hours or more. After boiling, the wort is cooled, inoculated with brewers yeast,
9
and fermented. The use of copper equipment during the prefermentation and
10
fermentation steps typically result in some leaching of copper.
11
Because copper is an essential nutrient for yeast growth, low levels of copper
12
are metabolized by the yeast during fermentation. However, studies have shown
13
that copper levels above 0.2 mg/L are toxic or lethal to the yeast. In addition,
14
copper levels as low as 3.5 mg/L have been reported to cause symptoms of
15
copper poisoning in humans.
16
successful beer fermentation (i.e., below 0.2 mg/L) do not reach a level that
17
would be toxic to humans.
18
Today, domestic beer brewers typically endeavor to use only stainless steel or
19
stainless steel-lined copper equipment (piping, fermenters, filters, holding tanks,
20
bottling machines, keys, etc.) in contact with beer following the hot brewing steps
21
in the beer making process. Some also use pitch-coated oak vats or glass-lined
22
steel vats following the hot brewing steps. Where copper equipment is not used
23
in beer brewing, it is common practice to add copper (along with zinc) to provide
24
the nutrients essential to the yeast for successful fermentation.
25
4-101.15
Therefore, the levels of copper necessary for
Galvanized Metal, Use Limitation.*
26
Galvanized means iron or steel coated with zinc, a heavy metal that may be
27
leached from galvanized containers into foods that are high in water content.
28
The risk of leaching increases with increased acidity of foods contacting the
29
galvanized container.
30
4-101.16
Sponges, Use Limitation.
Guam Food Code Annex 1 – Public Health Reasons
169
1
Sponges are difficult, if not impossible, to clean once they have been in contact
2
with food particles and contaminants that are found in the environment. Because of
3
their construction, sponges provide harborage for any number and variety of
4
microbiological organisms, many
5
sponges are to be used only where they will not contaminate cleaned and
6
sanitized or in-use, food-contact surfaces such as for cleaning equipment and
7
utensils before rinsing and sanitizing.
4-101.17
8
9
of
The limited acceptance of the
which may be pathogenic.
Therefore,
Wood, Use Limitation.
use
of
wood as a food-contact surface is
10
determined by the nature of the food and the type of wood used. Moist foods
11
may cause the wood surface to deteriorate and the surface may become difficult
12
to clean. In addition, wood that is treated with preservatives may result in illness
13
due to the migration of the preservative chemicals to the food; therefore, only
14
specific preservatives are allowed.
4-101.18
15
Nonstick Coatings, Use Limitation.
16
Perfluorocarbon resin is a tough, nonporous and stable plastic material that
17
gives cookware and bakeware a surface to which foods will not stick and that
18
cleans easily and quickly. FDA has approved the use of this material as safe for
19
food-contact surfaces. The Agency has determined that neither the particles that
20
may chip off nor the fumes given off at high temperatures pose a health hazard.
21
However, because this nonstick finish may be scratched by sharp or rough-
22
edged kitchen tools, the manufacturer's recommendations should be consulted
23
and the use of utensils that may scratch, abrasive scouring pads, or cleaners
24
avoided.
4-101.19
25
Nonfood-Contact Surfaces.
26
Nonfood-contact surfaces of equipment routinely exposed to splash or food
27
debris are required to be constructed of nonabsorbent materials to facilitate
28
cleaning.
29
pathogenic organisms, moisture, and debris and deters the attraction of rodents
30
and insects.
Equipment
that
is easily cleaned
minimizes
Guam Food Code Annex 1 – Public Health Reasons
170
the presence of
4-102.11
Characteristics.*
1
Single-Service
2
and Single-Use
3
The safety and quality of food can be adversely affected through single service
4
and single use articles that are not constructed of acceptable materials. The
5
migration of components of those materials to food they contact could result in
6
chemical contamination and illness to the consumer. In addition, the use of
7
unacceptable materials could adversely affect the quality of the food because of
8
odors, tastes, and colors transferred to the food.
9
Durability and
4-201.11
Equipment and Utensils.
10
Strength
11
Equipment and utensils must be designed and constructed to be durable and
12
capable of retaining their original characteristics so that such items can
13
continue to fulfill their intended purpose for the duration of their life expectancy
14
and to maintain their easy cleanability. If they can not maintain their original
15
characteristics, they may become
16
harborage of pathogenic microorganisms, insects, and rodents. Equipment and
17
utensils must
18
end up in food as foreign objects or present injury hazards to consumers. A
19
common example of presenting an injury hazard is the tendency for tines of
20
poorly designed single service forks to break during use.
21
4-201.12
difficult to clean,
allowing for the
be designed and constructed so that parts do not break and
Food Temperature Measuring Devices.*
22
Food temperature measuring devices that have glass sensors or stems
23
present a likelihood that glass will end up in food as a foreign object and create
24
an injury hazard to the consumer. In addition, the contents of the temperature
25
measuring device, e.g., mercury, may contaminate food or utensils.
26
Cleanability 4-202.11
27
The purpose of the requirements for multiuse food-contact surfaces is to
28
ensure that such surfaces are capable of being easily cleaned and accessible
29
for cleaning. Food-contact surfaces that do not meet these requirements provide
30
a potential harbor for foodborne pathogenic organisms. Surfaces which have
Food-Contact Surfaces.*
Guam Food Code Annex 1 – Public Health Reasons
171
1
imperfections such as cracks, chips, or pits allow microorganisms to attach and
2
form biofilms. Once established, these biofilms can release pathogens to food.
3
Biofilms are highly resistant to cleaning and sanitizing efforts. The requirement
4
for
5
disassemble and clean equipment if the task is difficult or requires the use of
6
special, complicated tools.
easy
disassembly recognizes the
4-202.12
7
reluctance of
food employees to
CIP Equipment.
8
Certain types of equipment are designed to be cleaned in place (CIP) where it
9
is difficult or impractical to disassemble the equipment for cleaning. Because
10
of the closed nature of the system, CIP cleaning must be monitored via access
11
points to ensure that cleaning has been effective throughout the system.
12
The CIP design must ensure that all food-contact surfaces of the equipment
13
are contacted by the circulating cleaning and sanitizing solutions. Dead spots
14
in the system, i.e., areas which are not contacted by the cleaning and sanitizing
15
solutions, could result in the buildup of food debris and growth of pathogenic
16
microorganisms. There is equal concern that cleaning and sanitizing solutions
17
might be retained in the system,
18
adulteration of food. Therefore, the CIP system must be self-draining.
4-202.13
19
which
may
result in
the
inadvertent
“V” Threads, Use Limitation.
20
V-type threads present a surface which is difficult to clean routinely; therefore,
21
they are not allowed on food-contact surfaces. The exception provided for hot oil
22
cooking fryers and filtering systems is based on the high temperatures that
23
are
24
equipment, including debris in the “V” threads.
used in this equipment.
4-202.14
25
facilitate
and
ensure
The high temperature in effect sterilizes the
Hot Oil Filtering Equipment.
26
To
effective
cleaning
of
this equipment, Code
27
requirements, §§ 4-202.11 and 4-202.12 must be followed. The filter is designed
28
to keep the oil free of undesired materials and therefore must be readily
29
accessible for replacement. Filtering the oil reduces the likelihood that off-
30
odors, tastes, and possibly toxic compounds may be imparted to food as a result
Guam Food Code Annex 1 – Public Health Reasons
172
1
of debris buildup. To ensure that filtering occurs, it is necessary for the filter
2
to be accessible for replacement.
3
4-202.15
can
openers become
Can Openers.
4
Once
5
uncleanable, they must be replaced because they can no longer be adequately
6
cleaned
7
replacement.
and
sanitized.
Can
4-202.16
8
pitted or the surface in any way becomes
openers
must
be
designed to
facilitate
Nonfood-Contact Surfaces.
9
Hard-to-clean areas could result in the attraction and harborage of insects and
10
rodents and allow the growth of foodborne pathogenic microorganisms. Well-
11
designed equipment enhances the ability to keep nonfood-contact surfaces
12
clean.
4-202.17
13
Kick Plates, Removable.
14
The use of kick plates is required to allow access for proper cleaning. If kick
15
plate design and installation does not meet Code requirements, debris could
16
accumulate and create a situation that may attract insects and rodents.
17
Accuracy
18
The Metric Conversion Act of 1975 (amended 1988, 1996, and 2004, 15 USC
19
205a et seq) requires that all Federal government regulations use the Celsius
20
Scale for temperature measurement. The Fahrenheit scale is included in the
21
Code for those jurisdictions using the Fahrenheit scale for temperature
22
measurement.
23
The small margin of error specified for thermometer accuracy is due to the lack
24
of a large safety margin in the temperature
25
accuracy
26
applicable to its entire range of use, that is, from refrigeration through cooking
27
temperatures if the device is intended for such use.
4-203.11
Temperature Measuring Devices, Food.
specified for a particular food
requirements themselves. The
temperature
Guam Food Code Annex 1 – Public Health Reasons
173
measuring device is
1
4-203.12
Temperature Measuring Devices, Ambient Air and Water.
2
A temperature measuring device used to measure the air temperature in a
3
refrigeration unit is not required to be as accurate as a food thermometer
4
because the unit's temperature fluctuates with repeated opening and closing of
5
the door and because accuracy in measuring internal food temperatures is of
6
more significance.
7
The Celsius scale is the federally recognized scale based on The Metric
8
Conversion Act of 1975 (amended 1988, 1996, and 2004, 15 USC 205a et seq)
9
which requires the use of metric values.
The ±1.5oC requirement is more
10
stringent than the 3oF previously required since ±1.5oC is equivalent to
11
±2.7oF. The more rigid accuracy results from the practical application of metric
12
equivalents to the temperature gradations of Celsius thermometers.
13
If Fahrenheit thermometers are used, the 3oF requirement applies because of
14
the calibrated intervals of Fahrenheit thermometers.
15
The accuracy specified for a particular air or water temperature measuring
16
device is applicable to its intended range of use. For example, a cold holding
17
unit may have a temperature measuring device that measures from a
18
specified frozen temperature to 20oC (68oF). The device must be accurate to
19
specifications within that use range.
4-203.13
20
Pressure Measuring Devices, Mechanical
Warewashing Equipment.
21
22
Flow
pressure
is
a very
23
sanitization. A pressure below the design pressure results in inadequate spray
24
patterns and incomplete coverage
25
Excessive flow pressure will tend to atomize the water droplets needed to
26
convey heat into a vapor mist that cools before reaching the surfaces to be
27
sanitized.
28
Functionality
29
The dripping of grease or condensation onto food constitutes adulteration and
30
may involve contamination of the food with pathogenic organisms. Equipment,
4-204.11
important factor with respect to the efficacy of
of the utensil surfaces to be sanitized.
Ventilation Hood Systems, Drip Prevention.
Guam Food Code Annex 1 – Public Health Reasons
174
1
utensils, linens, and single service and single use articles that are subjected to
2
such drippage are no longer clean.
4-204.12
3
Equipment Openings, Closures and Deflectors.
4
Equipment openings and covers must be designed to protect stored or
5
prepared food from contaminants and foreign matter that may fall into the food.
6
The requirement for an opening to be flanged upward and for the cover to
7
overlap the opening and be sloped to drain prevents contaminants, especially
8
liquids, from entering the food-contact area.
9
Some equipment may have parts that extend into the food-contact areas. If these
10
parts are not provided with a watertight joint at the point of entry into the food-
11
contact area, liquids may contaminate the food by adhering to shafts or other
12
parts and running or dripping into the food.
13
An
14
alternative to the watertight seal. If the apron is not properly designed and
15
installed, condensation, drips, and dust may gain access to the food.
16
4-204.13
17
This
18
unpackaged, liquid foods and the machine components from contamination.
19
Barriers need to be provided so that the only liquid entering the food container is
20
the liquid intended to be dispensed when the machine's mechanism is activated.
21
Recessing of the machine's components and self-closing doors prevent
22
contamination of machine ports by people, dust, insects, or rodents.
23
equipment components become contaminated, the product itself will be
24
exposed to possible contamination.
25
A direct opening into the food being dispensed allows dust, vermin, and other
26
contaminants access to the food.
27
apron
on parts extending into the
food-contact area is an acceptable
Dispensing Equipment, Protection of Equipment and Food.
requirement
4-204.14
is
intended to protect
both the machine-dispensed,
If the
Vending Machine, Vending Stage Closure.
28
Since packaged foods dispensed from vending machines could attract insects
29
and rodents, a self-closing door is required as a barrier to their entrance.
30
4-204.15
Bearings and Gear Boxes, Leakproof.
Guam Food Code Annex 1 – Public Health Reasons
175
1
It is not unusual for food equipment to contain bearings and gears. Lubricants
2
necessary for the operation of these types of equipment could contaminate
3
food or food-contact surfaces if the equipment is not properly designed and
4
constructed.
4-204.16
5
Beverage Tubing, Separation.
6
Beverage tubing and coldplate cooling devices may result in contamination if
7
they are installed in direct contact with stored ice. Beverage tubing installed in
8
contact with ice may result in condensate and drippage contaminating the ice
9
as the condensate moves down the beverage tubing and ends up in the ice.
10
The presence of beverage tubing and/or coldplate cooling devices also
11
presents cleaning problems. It may be difficult to adequately clean the ice bin if
12
they are present. Because of the high moisture environment, mold and algae
13
may form on the surface of the ice bins and any tubing or equipment stored
14
in the bins.
15
4-204.17
Ice Units, Separation of Drains.
16
Liquid waste drain lines passing through ice machines and storage bins
17
present a risk of contamination due to potential leakage of the waste lines and
18
the possibility that contaminants will gain access to the ice through condensate
19
migrating along the exterior of the lines.
20
Liquid drain lines passing through the ice bin are, themselves, difficult to clean
21
and create other areas that are difficult to clean where they enter the unit as well
22
as where they abut other surfaces. The potential for mold and algal growth in
23
this area is very likely due to the high moisture environment.
24
algae that form on the drain lines are difficult to remove and present a risk of
25
contamination to the ice stored in the bin.
26
4-204.18
Molds and
Condenser Unit, Separation.
27
A dust-proof barrier between a condenser and food storage areas of
28
equipment protects food and food-contact areas from contamination by dust that
29
is accumulated and blown about as a result of the condenser's operation.
30
4-204.19
Can Openers on Vending Machines.
Guam Food Code Annex 1 – Public Health Reasons
176
1
Since the cutting or piercing surfaces of a can opener directly contact food in
2
The container being opened, these surfaces must be protected from
3
contamination.
4-204.110
4
Molluscan Shellfish Tanks.
5
Shellfish are filter feeders allowing concentration of pathogenic microorganisms
6
that may be present in the water.
7
limited volume of water used, display
8
pathogenic viruses and bacteria.
9
Since many people eat shellfish either raw or lightly cooked, the potential for
10
increased levels of pathogenic microorganisms in shellfish held in display tanks
11
is of concern.
12
consumption, certain safeguards must be in place as specified in a detailed
13
HACCP plan that is approved by the regulatory authority.
14
contamination must be controlled or eliminated. Procedures must emphasize
15
strict monitoring of the water quality of the tank including the filtering and
16
disinfection system.
shellfish and the
tanks may allow concentration of
If shellfish stored in molluscan shellfish tanks are offered for
4-204.111
17
Due to the number of
Opportunities for
Vending Machines, Automatic Shutoff.*
18
Failure to store potentially hazardous (time/temperature control for safety) food at
19
safe temperatures in a vending machine could result in the growth of pathogenic
20
microorganisms
21
automatic control that prevents the vending of food if the temperature of the unit
22
exceeds Code requirements precludes the vending of foods that may not be
23
safe.
24
It is possible and indeed very likely that the temperature of the storage area
25
of a vending machine may exceed Code requirements during the stocking and
26
servicing of the machine. The automatic shut off, commonly referred to as the
27
“public health control,” provides a limited amount of time that the ambient
28
temperature of a machine may exceed Code requirements. Strict adherence to
29
the time requirements can limit the growth of pathogenic microorganisms.
30
that may result in foodborne illness.
4-204.112
The presence of an
Temperature Measuring Devices.
Guam Food Code Annex 1 – Public Health Reasons
177
1
The placement of the temperature measuring device is important.
2
device is placed in the coldest location in the storage unit, it may not be
3
representative of the temperature of the unit. Food could be stored in areas of
4
the unit that exceed Code requirements. Therefore, the temperature measuring
5
device must be placed in a location that is representative of the actual
6
storage
7
(time/temperature control for safety) foods are stored at least at the minimum
8
temperature required in Chapter 3.
9
Installing an air thermometer in some open display refrigerators can be difficult
10
without physically impairing the usability of the case and interfering with
11
cleaning and sanitation. Use of a temperature monitoring system that uses probe-
12
like sensors that are placed in material resembling the density of food is an
13
acceptable alternative. Thus, the direct temperature of the substitute product is
14
measured by use of this product mimicking method.
15
A permanent temperature measuring
16
potentially hazardous (time/temperature control for safety) food because of the
17
potential growth of pathogenic microorganisms should the temperature of the
18
unit exceed Code requirements. In order to facilitate routine monitoring of the
19
unit, the device must be clearly visible.
20
The exception to requiring a temperature measuring device for the types of
21
equipment listed is primarily due to equipment design and function. It would be
22
difficult and impractical to permanently mount a temperature measuring device
23
on the equipment listed. The futility of attempting to measure the temperature of
24
unconfined air such as with heat lamps and, in some cases, the brief period of
25
time the equipment is used for a given food negate the usefulness of ambient
26
temperature monitoring at that point. In such cases, it would be more practical
27
and accurate to measure the internal temperature of the food.
28
The importance of maintaining potentially hazardous (time/temperature control
29
for safety) foods at the specified
temperature
If the
of the unit to ensure that all potentially hazardous
device is required in any unit storing
temperatures requires that temperature
Guam Food Code Annex 1 – Public Health Reasons
178
1
measuring devices be easily readable.
2
thermometer could result in food being held at unsafe temperatures.
3
Temperature measuring devices must be appropriately scaled per Code
4
requirements to ensure accurate readings.
5
The required incremental gradations are
6
devices than for those used to measure ambient temperature because of the
7
significance at a given point in time, i.e., the potential for pathogenic growth,
8
versus the unit's temperature. The food temperature will not necessarily match
9
the ambient temperature of the storage unit; it will depend on many variables
food
The inability to accurately read a
more
when
precise for food measuring
10
including the temperature of the
it
is placed in the unit, the
11
temperature at which the unit is maintained, and the length of time the food is
12
stored in the unit.
13
4-204.113
Warewashing Machine, Data Plate Operating
Specifications.
14
15
The data plate provides the operator with the fundamental information needed
16
to ensure that the machine is effectively
17
equipment and utensils. The warewashing machine has been tested, and the
18
information on the data plate represents the parameters that ensure effective
19
operation and sanitization and that need to be monitored.
4-204.114
20
washing, rinsing, and sanitizing
Warewashing Machines, Internal Baffles.
21
The presence of baffles or curtains separating the various operational cycles
22
of a warewashing machine such as washing, rinsing, and sanitizing are
23
designed
24
contaminate solutions in another. The baffles or curtains also prevent food
25
debris from being splashed onto the surface of equipment that has moved to
26
another cycle in the procedure.
27
to
4-204.115
reduce the
possibility that
solutions
from one cycle
may
Warewashing Machines, Temperature Measuring Devices.
28
The requirement for the presence of a temperature measuring device in each
29
tank of the warewashing machine is based on the importance of temperature
30
in the sanitization step.
In hot water machines, it is critical that minimum
Guam Food Code Annex 1 – Public Health Reasons
179
1
temperatures
2
successively rising temperatures causes the surface of the item being washed
3
to reach the required temperature for sanitization. When chemical sanitizers are
4
used, specific minimum temperatures must be met because the effectiveness
5
of chemical sanitizers is directly affected by the temperature of the solution.
6
be met at the various cycles so that the cumulative effect of
4-204.116
Manual Warewashing Equipment, Heaters and Baskets.
7
Hot water sanitization is accomplished in water of not less than 77oC (170oF)
8
and an integral heating device is necessary to
9
temperature is reached.
ensure that the minimum
10
The rack or basket is required in order to safely handle the equipment and
11
utensils being washed and to ensure immersion. Water at this temperature
12
could result in severe burns to employees operating the equipment.
13
4-204.117
Warewashing Machines, Automatic Dispensing of
Detergents and Sanitizers.
14
15
The presence of adequate detergents
16
clean and sanitized utensils and equipment. The automatic dispensing of these
17
chemical agents, plus a method such as a flow indicator, flashing light, buzzer,
18
or visible open air delivery system that alerts the operator that the chemicals are
19
no longer being dispensed, ensures that utensils are subjected to an efficacious
20
cleaning and sanitizing regimen.
21
4-204.118
and sanitizers is necessary to effect
Warewashing Machines, Flow Pressure Device.
22
Flow pressure is a very important factor impacting the efficacy of sanitization in
23
machines that use fresh hot water at line-pressure as a final sanitization rinse.
24
(See discussion in Public Health Reason for section 4-203.13.) It is important
25
that the operator be able to monitor, and the food inspector be able to check,
26
final sanitization rinse pressure as well
27
ANSI/NSF Standard #3, a national voluntary consensus standard for Commercial
28
Spray-Type Dishwashing Machines, specifies
29
similar device be provided on this type machine and such devices are shipped
30
with machines by the manufacturer.
as
machine water temperatures.
that a pressure gauge or
Flow pressure devices installed on the
Guam Food Code Annex 1 – Public Health Reasons
180
1
upstream side of the control (solenoid) valve are subject to damage and failure
2
due to the water hammer effect caused throughout the dishwashing period
3
each time the control valve closes. The IPS valve provides a ready means for
4
checking line-pressure with an alternative pressure measuring device. A flow
5
pressure device is not required on
6
recirculated sanitizing rinse since an appropriate pressure is ensured by a pump
7
and is not dependent upon line-pressure.
8
4-204.121
machines
that use only a pumped or
Vending Machines, Liquid Waste Products.
9
The presence of internal waste containers allows for the collection of liquids
10
that spill within the vending machine. Absence of a waste container or, where
11
required, a shutoff valve which controls the incoming liquids could result in
12
wastes spilling within the machine, causing a condition that attracts insects and
13
rodents and compounds cleaning and maintenance problems.
14
4-204.122
Case Lot Handling Equipment, Moveability.
15
Proper design of case lot handling equipment facilitates moving case lots for
16
cleaning and for surveillance of insect or rodent activity.
17
4-204.123
Vending Machine Doors and Openings.
18
The objective of this requirement is to provide a barrier against the entrance into
19
vending machines of insects, rodents, and dust.
20
openings deters the entrance of common pests.
21
Acceptability
22
4-205.10
The maximum size of the
Food Equipment, Certification and
Classification.
23
Under ANSI document CA-1 ANSI Policy and Criteria for Accreditation of
24
Certification Programs, it has been stipulated that:
25
“For food equipment programs, standards that establish sanitation requirements
26
shall be specified government standards or standards that have been ratified by
27
a public health approval step. ANSI shall verify that this requirement has been
28
met by communicating with appropriate standards developing organizations and
29
governmental public health bodies.”
30
The term certified is used when an item of food equipment has been evaluated
Guam Food Code Annex 1 – Public Health Reasons
181
1
against an organization's own standard. The term classified is used when one
2
organization
3
developed by another organization.
4
Equipment 4-301.11
5
The ability of equipment to cool, heat, and maintain potentially hazardous
6
(time/temperature control for safety) foods at Code-required temperatures is
7
critical to food safety. Improper holding and cooking temperatures continue to be
8
major contributing factors to foodborne illness. Therefore, it is very important
9
to have adequate hot or cold holding equipment with enough capacity to meet
10
11
evaluates
an item
of
food equipment
against
a standard
Cooling, Heating, and Holding Capacities.
the heating and cooling demands of the operation.
4-301.12
Manual Warewashing, Sink Compartment Requirements.
12
The 3 compartment requirement allows for proper execution of the 3-step
13
manual warewashing procedure. If properly used, the 3 compartments reduce
14
the chance of contaminating the sanitizing water and therefore diluting the
15
strength and efficacy of the chemical sanitizer that may be used.
16
Alternative
17
circumstances and conditions, must provide for accomplishment of the same 3
18
steps:
manual
warewashing
equipment,
allowed
under certain
19
1.
Application of cleaners and the removal of soil;
20
2.
Removal of any abrasive and removal or dilution of cleaning
21
22
23
24
chemicals; and
3.
Sanitization.
Refer also to the public health reason for § 4-603.16.
4-301.13
Drainboards.
25
Drainboards or equivalent equipment are
necessary to separate soiled and
26
cleaned items from each other and from the food preparation area in order to
27
preclude contamination of cleaned items and of food.
28
Drainboards allow for the control of water running off equipment and utensils that
29
have been washed and also allow the
30
equipment and utensils while they air-dry.
operator to properly store washed
Guam Food Code Annex 1 – Public Health Reasons
182
4-301.14
1
Ventilation Hood Systems, Adequacy.
2
If a ventilation system is inadequate, grease and condensate may build up on
3
the floors, walls and ceilings of the food establishment, causing an insanitary
4
condition and possible deterioration of the surfaces of walls and ceilings. The
5
accumulation of grease and condensate may contaminate food and food-contact
6
surfaces as well as present a possible fire hazard.
7
Refer also to the public health reason for § 4-204.11.
4-301.15
8
Clothes Washers and Dryers.
9
To protect food, soiled work clothes or linens must be efficiently laundered.
10
The only practical way of efficiently laundering work clothes on the premises is
11
with the use of a mechanical washer and dryer.
12
Refer also to the public health reason for § 4-401.11.
13
Utensils,
14
Temperature
15
Measuring Devices, and
16
Testing Devices
17
Appropriate serving utensils provided
18
things, reduce the likelihood of food tasting, use of fingers to serve food, use of
19
fingers to remove the remains of one food on the utensil so that it may be used
20
for another, use of soiled tableware to transfer food, and cross contamination
21
between foods, including a raw food to a cooked potentially hazardous
22
(time/temperature control for safety) food.
23
4-302.11
4-302.12
Utensils, Consumer Self-Service.
at each container will, among other
Food Temperature Measuring Devices.
24
The presence and accessibility of food temperature measuring devices is
25
critical to the effective monitoring of food temperatures. Proper use of such
26
devices provides the operator or person in charge with important information
27
with which to determine if temperatures should be adjusted or if foods should
28
be discarded.
29
When determining the temperature of thin foods, those having a thickness less
30
than 13 mm (1/2 inch), it is particularly important to use a temperature sensing
Guam Food Code Annex 1 – Public Health Reasons
183
1
probe designed for that purpose. Bimetal, bayonet style thermometers are not
2
suitable for accurately measuring the
3
hamburger patties because of the large diameter of the probe and the inability
4
to
5
temperature measurements in thin foods can be accurately determined using a
6
small-diameter probe 1.5 mm (0.059 inch), or less, connected to a device such as
7
8
accurately
sense
the
temperature of thin foods such as
temperature at the tip of the probe.
However,
thermocouple thermometer.
4-302.13
Temperature Measuring Devices, Manual
Warewashing.
9
10
Water temperature is critical to sanitization in warewashing operations. This is
11
particularly true if the sanitizer being used is hot water. The effectiveness of
12
cleaners and chemical sanitizers is also determined by the temperature of the
13
water used. A temperature measuring device is essential to monitor manual
14
warewashing and ensure sanitization.
4-302.14
15
Sanitizing Solutions, Testing Devices.
16
Testing devices to measure the
17
required for 2 reasons:
18
1.
concentration
of sanitizing solutions are
The use of chemical sanitizers requires minimum concentrations
19
of the sanitizer during the final rinse step to ensure sanitization;
20
and
21
22
2.
Location
Too much sanitizer in the final rinse water could be toxic.
4-401.11
Equipment, Clothes Washers and Dryers, and
Storage Cabinets, Contamination Prevention.
23
24
Food equipment and the food that contacts the equipment must be protected from
25
sources of overhead contamination such as leaking or ruptured water or sewer
26
pipes, dripping condensate, and falling objects. When equipment is installed, it
27
must be situated with consideration of the potential for contamination from such
28
overhead sources.
Guam Food Code Annex 1 – Public Health Reasons
184
1
If a clothes washer and dryer are installed adjacent to exposed food, clean
2
equipment, utensils, linens, and unwrapped single-service and single-use
3
articles, it could result in those items becoming contaminated from soiled
4
laundry. The reverse is also true, i.e., items being laundered could become
5
contaminated
6
properly located.
7
Installation 4-402.11
8
This section is designed to ensure that fixed equipment is installed in a way
9
that:
10
1.
from the surrounding area if the washer and dryer are not
Fixed Equipment, Spacing or Sealing.
Allows accessibility for cleaning on all sides, above, and
11
underneath the units or minimizes the need for cleaning due to
12
closely abutted surfaces;
13
2.
Ensures that equipment that is subject to moisture is sealed;
14
3.
Prevents the harborage of insects and rodents; and
15
4.
Provides accessibility for the monitoring of pests.
16
4-402.12
Fixed Equipment, Elevation or Sealing.
17
The inability to adequately or effectively clean areas under equipment could
18
create a situation that may attract
19
pathogenic microorganisms that are transmissible through food.
20
The effectiveness of cleaning is directly affected by the ability to access all areas
21
to clean fixed equipment. It may be necessary to elevate the equipment. When
22
elevating equipment is not feasible or prohibitively expensive, sealing to prevent
23
contamination is required.
24
The economic impact of the requirement to elevate display units in retail food
25
stores, coupled with the fact that the design, weight, and size of such units are
26
not conducive to casters or legs, led to the exception for certain units located
27
in consumer shopping areas, provided the floor under the units is kept clean.
28
This exception for retail food store display equipment including shelving,
29
refrigeration, and freezer units in the consumer shopping areas requires a
30
rigorous cleaning schedule.
insects and rodents and accumulate
Guam Food Code Annex 1 – Public Health Reasons
185
1
Equipment 4-501.11
Good Repair and Proper Adjustment.
2
Proper maintenance of equipment to manufacturer specifications helps ensure
3
that it will continue to operate as designed.
4
equipment could lead to violations of the associated requirements of the Code
5
that place the health of the consumer at risk. For example, refrigeration units in
6
disrepair may no longer be capable of properly cooling or holding potentially
7
hazardous (time/temperature control for safety) foods at safe temperatures.
8
The cutting or piercing parts of can openers may accumulate metal fragments
9
that
Failure to properly maintain
could lead to food containing foreign objects and, possibly, result in
10
consumer injury.
11
Adequate cleaning and sanitization of dishes and utensils using a warewashing
12
machine is directly dependent on the exposure time during the wash, rinse, and
13
sanitizing cycles. Failure to meet manufacturer and Code requirements for cycle
14
times could result in failure to clean and sanitize. For example, high temperature
15
machines depend on the buildup of heat on the surface of dishes to accomplish
16
sanitization. If the exposure time during any of the cycles is not met, the
17
surface of the items may not reach the time-temperature parameter required
18
for sanitization. Exposure time is also important in warewashing machines that
19
use a chemical sanitizer since the sanitizer must contact the items long enough
20
for sanitization to occur. In addition, a chemical sanitizer will not sanitize a dirty
21
dish; therefore, the cycle times during the wash and rinse phases are critical to
22
sanitization.
Guam Food Code Annex 1 – Public Health Reasons
186
4-501.12
1
Cutting Surfaces.
2
Cutting surfaces such as cutting boards and blocks that become scratched and
3
scored may be difficult to clean and sanitize.
4
microorganisms transmissible through food may build up or accumulate. These
5
microorganisms
6
surfaces.
may
be transferred to foods that
4-501.13
7
As a result, pathogenic
are prepared on such
Microwave Ovens.
8
Failure of microwave ovens to meet the CFR standards could result in human
9
exposure to radiation leakage, resulting
10
11
in possible medical problems to
consumers and employees using the machines.
4-501.14
Warewashing Equipment, Cleaning Frequency.
12
With the passage of the Food Quality Protection Act of 1996 and the related
13
Antimicrobial Regulation Technical Correction Act of 1998, federal regulatory
14
responsibility for chemical hard surface sanitizers was moved from FDA
15
(CFSAN/OFAS) to EPA (Office of Pesticides Programs, Antimicrobial Division).
16
As a result, the relevant Federal regulation has moved from 21 CFR 178.1010
17
to 40 CFR 180.940.
18
During operation, warewashing equipment is subject to the accumulation of
19
food wastes and other soils or sources of contamination. In order to ensure the
20
proper cleaning and sanitization of equipment and utensils, it is necessary to
21
clean the surface of warewashing
22
throughout the day.
23
With respect to chemical sanitization, section 4-501.114 addresses the proper
24
make-up of the sanitizing solution, i.e., chemical concentration, pH, and
25
temperature at the required minimum levels specified when considered together
26
and, with respect to quaternary ammonium compounds (quats), the maximum
27
hardness level. If these minimums (maximum hardness) are not as specified,
28
then this provision is violated.
29
By contrast, paragraph 4-703.11(C) addresses exposure time in seconds. For
30
chemical sanitization, this paragraph is
equipment before use and periodically
only violated
Guam Food Code Annex 1 – Public Health Reasons
187
when
the
specified
1
exposure time is not met.
2
Section 7-204.11 addresses two additional considerations. The first is whether
3
or not the chemical agent being applied as a sanitizer is approved and listed for
4
that use under 40 CFR 180.940. If the chemical used is not thus listed, this
5
section is violated.
6
The second consideration under this section is whether the product, if approved
7
and listed, is being used in accordance with the “Limits” provided for that
8
product under its 40 CFR 180.940 listing. The concern here is an indirect food
9
additives concern, since chemical sanitizing solutions are not rinsed off in this
10
country. For example, 40 CFR 180.940(a) lists several quaternary ammonium
11
compounds
12
dairy-processing equipment, and food-processing equipment and utensils,” each
13
listing adding a Limit that states,
14
concentration of all
15
200 ppm of active quaternary compound. If a sanitarian determined that a solution
16
of any of these quats was at 600 ppm, section 7-204.11 would be violated.
17
To summarize, a too weak sanitizing solution would be a violation of section
18
4- 501.114.
19
Section 7-202.12 would not be violated due to the existence of section 7-204.11
20
that specifically addresses the use chemical sanitizers.
as approved for “food-contact surfaces in public eating places,
ready
for
use,
the
end-use
quaternary chemicals in the solution is not to exceed
A too strong solution would be a violation of section 7-204.11.
4-501.15
21
“When
Warewashing Machines, Manufacturers'
Operating Instructions.
22
23
To ensure properly cleaned and sanitized equipment and utensils, warewashing
24
machines must be operated properly. The manufacturer affixes a data plate to
25
the machine providing vital, detailed instructions about the proper operation of
26
the
27
temperatures which must be achieved.
28
machine
4-501.16
including
wash,
rinse, and
sanitizing
cycle
times
and
Warewashing Sinks, Use Limitation.
29
If the wash sink is used for functions other than warewashing, such as washing
30
wiping cloths or washing and thawing foods, contamination of equipment and
Guam Food Code Annex 1 – Public Health Reasons
188
1
utensils could occur.
4-501.17
2
Warewashing Equipment, Cleaning Agents.
3
Failure to use detergents or cleaners in accordance with the manufacturer's
4
label instructions could create safety concerns for the employee and consumer.
5
For example, employees could suffer chemical burns, and chemical residues
6
could find their way into food if detergents or cleaners are used carelessly.
7
Equipment or utensils may not be cleaned if inappropriate or insufficient
8
amounts of cleaners or detergents are used.
4-501.18
9
Warewashing Equipment, Clean Solutions.
10
Failure to maintain clean wash, rinse, and sanitizing solutions adversely affects
11
the warewashing operation. Equipment and utensils may not be sanitized,
12
resulting in subsequent contamination of food.
13
4-501.19
14
The wash solution temperature required in the Code is essential for removing
15
organic matter.
16
detergent may be adversely affected, e.g., animal fats that may be present
17
on the dirty dishes would not be dissolved.
18
19
Manual Warewashing Equipment, Wash Solution Temperature.
If the temperature is
4-501.110
below 110oF, the performance of the
Mechanical Warewashing Equipment, Wash
Solution Temperature.
20
The wash solution temperature in mechanical warewashing equipment is
21
critical to proper operation.
22
their function if the temperature is too low.
23
instructions must be followed. The temperatures vary according to the specific
24
equipment being used.
The chemicals used may not adequately perform
Therefore, the manufacturer's
Guam Food Code Annex 1 – Public Health Reasons
189
4-501.111
1
Manual Warewashing Equipment, Hot Water
Sanitization Temperatures.*
2
3
If the temperature during the hot water sanitizing step is less than 77oC
4
(171oF), sanitization will not be achieved. As a result, pathogenic organisms
5
may survive and be subsequently transferred from utensils to food.
6
4-501.112
Mechanical Warewashing Equipment, Hot Water Sanitization
7
Temperatures.
8
The temperature of hot water delivered
9
manifold must be maintained according to the equipment manufacturer‟s
10
specifications and temperature limits specified in this section to ensure surfaces
11
of multiuse utensils such as kitchenware and tableware accumulate enough
12
heat to destroy pathogens that may remain on such surfaces after cleaning.
13
The surface temperature must reach at least 71ºC (160ºF) as measured by an
14
irreversible registering temperature measuring device to affect sanitization.
15
When the sanitizing rinse temperature exceeds 90ºC (194ºF) at the manifold,
16
the water becomes volatile and begins to vaporize reducing its ability to
17
convey sufficient heat to utensil surfaces. The lower temperature limits of 74ºC
18
(165ºF) for a stationary rack, single temperature machine, and 82ºC (180ºF)
19
for other machines are based on the sanitizing rinse contact time required
20
to achieve the 71ºC (160ºF) utensil surface temperature.
4-501.113
21
from a warewasher sanitizing rinse
Mechanical Warewashing Equipment, Sanitization Pressure.
22
If
23
dispersion of the sanitizing solution may be inadequate to reach all surfaces
24
of equipment or utensils.
25
4-501.114
26
the flow pressure of the final sanitizing rinse is less than that required,
Manual and Mechanical Warewashing Equipment, Chemical
Sanitization - Temperature, pH, Concentration, and Hardness.*
27
With the passage of the Food Quality Protection Act of 1996 and the related
28
Antimicrobial Regulation Technical Correction Act of 1998, Federal regulatory
29
responsibility for chemical hard surface sanitizers was moved from FDA
30
(CFSAN/OFAS) to EPA (Office of Pesticides Programs, Antimicrobial Division).
Guam Food Code Annex 1 – Public Health Reasons
190
1
As a result, the relevant Federal regulation has moved from 21 CFR 178.1010
2
to 40 CFR 180.940.
3
The effectiveness of chemical
4
temperature, pH, concentration of the sanitizer solution used, and hardness of
5
the water. All sanitizers approved for use under 40 CFR 180.940 must be used
6
under water conditions stated on the label to ensure efficacy. Therefore, it is
7
critical to sanitization that the sanitizers are used properly and the solutions
8
meet the minimum standards required in the Code.
9
With respect to chemical sanitization, section 4-501.114 addresses the proper
10
make-up of the sanitizing solution, i.e., chemical concentration, pH, and
11
temperature at the required maximum levels
12
together and, with respect to quaternary ammonium compounds (quats), the
13
maximum hardness level. If these minimums (maximum hardness) are not as
14
specified, then this provision is violated.
15
By contrast, paragraph 4-703.11(C) addresses exposure time in seconds. For
16
chemical
17
exposure time is not met.
18
Section 7-204.11 addresses two additional considerations. The first is whether or
19
not the chemical agent being applied as a sanitizer is approved and listed for
20
that use under 40 CFR 180.940. If the chemical used is not thus listed, this
21
section is violated.
22
The second consideration under this section is whether the product, if
23
approved and listed, is being used in accordance with the “Limits” provided
24
for that product under its 40 CFR 180.940 listing. The concern here is an
25
indirect food additives concern, since chemical sanitizing solutions are not rinsed
26
off in this country. For example, 40 CFR 180.940(a) lists several quaternary
27
ammonium compounds as approved for “food-contact
28
eating places, dairy-processing equipment, and food-processing equipment
29
and utensils,” each listing adding a Limit that states, “When ready for use, the
30
end-use concentration of all quaternary chemicals in the solution is not to
sanitizers can be directly affected by the
sanitization, this paragraph
is
only
specified when considered
violated when the specified
Guam Food Code Annex 1 – Public Health Reasons
191
surfaces in public
1
exceed 200 ppm of active quaternary compound.” If a sanitarian determined
2
that a solution of any of these quats was at 600 ppm, section 7-204.11 would
3
be violated.
4
To summarize, a too weak sanitizing solution would be a violation of section 4-
5
501.114. A too strong solution would be a violation of section 7-204.11. Section
6
7-202.12 would not be violated due to the existence of section 7-204.11 that
7
specifically addresses the use chemical sanitizers.
4-501.115
8
Manual Warewashing Equipment, Chemical
Sanitization Using Detergent-Sanitizers.
9
10
Some chemical sanitizers are not compatible with detergents when a 2 compartment
11
operation is used. When using a sanitizer that is different from the detergent-
12
sanitizer of the wash compartment, the sanitizer may be inhibited by carry-
13
over, resulting in inadequate sanitization.
14
4-501.116
Warewashing Equipment, Determining Chemical Sanitizer
Concentration.
15
16
The effectiveness of chemical sanitizers is determined primarily by the
17
concentration and pH of the sanitizer solution. Therefore, a test kit is
18
necessary to accurately determine the concentration of the chemical sanitizer
19
solution.
20
Utensils and
21
Temperature
22
and Pressure
23
Measuring Devices
24
A utensil or food temperature measuring device can act as a source of
25
contamination to the food it contacts if it is not maintained in good repair.
26
Also, if temperature or pressure measuring devices are not maintained in good
27
repair,
28
temperature problem may not be detected, or conversely, a corrective action
29
may be needlessly taken.
30
the
4-502.12
4-502.11
accuracy of
the
Good Repair and Calibration.
readings is questionable.
Consequently, a
Single-Service and Single-Use Articles, Required Use.*
Guam Food Code Annex 1 – Public Health Reasons
192
1
In situations in which the reuse of multiuse items could result in foodborne illness
2
to consumers, single-service and single-use articles must be used to ensure
3
safety.
4-502.13
4
Single-Service and Single-Use Articles, Use
Limitation.
5
6
Articles that are not constructed of multiuse materials may not be reused as
7
they are unable to withstand the rigors of multiple uses, including the ability to
8
be subjected to repeated washing, rinsing, and sanitizing.
4-502.14
9
Shells, Use Limitation.
10
The reuse of mollusk and crustacean shells as multiuse utensils is not allowed
11
in food establishments.
12
oyster or other species from the shell for preparation, then returning the same
13
animal to the same shell for service.
14
The shell itself may be potentially unsafe for use as a food utensil because of
15
residues from natural and
16
mollusk or crustacean is removed. In addition, natural shells are not durable or
17
easily cleanable as specified
18
crustacean shells (from commercial sources) are re-used by filling them with
19
shucked
20
presented.
21
Objective
shellfish,
This prohibition does not apply to the removal of the
environmental
under
the food is
4-601.11
contamination occurring after the
section 4-502.13.
When mollusk or
considered misleading and
not
honestly
Equipment, Food-Contact Surfaces, NonfoodContact Surfaces, and Utensils.*
22
23
The objective of cleaning focuses on the need to remove organic matter from
24
food-contact surfaces so that sanitization can occur and to remove soil from
25
nonfood contact surfaces so that pathogenic microorganisms will not be allowed
26
to accumulate and insects and rodents will not be attracted.
27
Frequency 4-602.11
28
Microorganisms may be transmitted from a food to other foods by utensils,
29
cutting boards, thermometers, or other food-contact surfaces.
30
surfaces and equipment used for potentially hazardous (time/temperature control
Equipment Food-Contact Surfaces and Utensils.*
Guam Food Code Annex 1 – Public Health Reasons
193
Food-contact
1
for safety) foods should be cleaned as needed throughout the day but must
2
be
3
microorganisms on those surfaces.
4
Refrigeration
5
pathogens, making it unnecessary to clean every four hours. However, the time
6
period between cleaning equipment and utensils may not exceed 24 hours. A
7
time-temperature chart is
8
accommodate operations that use equipment and utensils in a refrigerated
9
room or area that maintains a temperature between 41oF or less and 55oF.
cleaned
no
less than every 4
temperatures
slow down
hours
to prevent
the
growth
of
the
generation
time of bacterial
provided in subparagraph 4-602.11(D)(2) to
10
Surfaces of utensils
and equipment contacting food that is not potentially
11
hazardous
12
dispensers, carbonated beverage dispenser nozzles, beverage dispensing
13
circuits or lines, water vending equipment, coffee bean grinders, ice makers,
14
and ice bins must be cleaned on a routine basis to prevent the development
15
of slime, mold, or soil residues that may contribute to an accumulation of
16
microorganisms. Some equipment manufacturers and industry associations, e.g.,
17
within the tea industry, develop guidelines for regular cleaning and sanitizing of
18
equipment. If the manufacturer does not provide cleaning specifications for
19
food-contact surfaces of equipment that are not readily visible, the person in
20
charge should develop a cleaning regimen that is based on the soil that may
21
accumulate in those particular items of equipment.
22
Regarding the possible adulteration from one species of meat to another
23
between cleaning of food-contact surfaces, USDA/FSIS does not automatically
24
consider species adulteration as a health hazard. FSIS stated in an Advance
25
Notice of Proposed Rulemaking that species adulteration falls into a gray area
26
between safety and economic adulteration (65 FR 14486, March 17, 2000,
27
Other
28
received on the species adulteration issue and further review the scientific
29
literature
30
adulteration a health hazard. Meanwhile, species adulteration is generally
(time/temperature
Consumer
and risk
control
Protection Activities).
assessment
for
safety food) such as
FSIS will review public comments
mechanisms
before
Guam Food Code Annex 1 – Public Health Reasons
194
iced tea
declaring species
1
considered by FSIS as an economic issue. However, investigations by FSIS
2
of species adulteration incidents may include a determination regarding the
3
impact of species adulteration as a health hazard on a case-by-case basis.
4-602.12
4
Cooking and Baking Equipment.
5
Food-contact surfaces of cooking equipment must be cleaned to prevent
6
encrustations that may impede heat transfer necessary to adequately cook
7
food. Encrusted equipment may also serve as an insect attractant when not in
8
use. Because of the nature of the equipment, it may not be necessary to
9
clean cooking equipment as frequently as the equipment specified in § 4-
10
602.11.
4-602.13
11
Nonfood-Contact Surfaces.
12
The presence of food debris or dirt on nonfood contact surfaces may
13
provide a suitable environment for the growth of microorganisms which employees
14
may inadvertently transfer to food. If these areas are not kept clean, they
15
may also provide harborage for insects, rodents, and other pests.
16
Methods
17
Dry cleaning methods are indicated in only a few operations, which are
18
limited to dry foods that are not potentially hazardous (time/temperature control
19
for safety foods). Under some circumstances, attempts at wet cleaning may
20
create microbiological concerns.
4-603.11
Dry Cleaning.
4-603.12
21
Precleaning.
22
Precleaning of utensils, dishes, and food equipment allows for the removal of
23
grease and food debris to
24
Depending upon the condition of the surface to be cleaned, detergent alone
25
may not be sufficient to loosen soil for cleaning. Heavily soiled surfaces may
26
need to be presoaked or scrubbed with an abrasive.
27
4-603.13
facilitate
the cleaning action of the detergent.
Loading of Soiled Items, Warewashing Machines.
28
Items to be washed in a warewashing machine must receive unobstructed
29
exposure to the spray to ensure adequate cleaning. Items which are stacked
30
or trays which are heavily loaded with silverware cannot receive complete
Guam Food Code Annex 1 – Public Health Reasons
195
1
distribution of detergent, water, or sanitizer and cannot be considered to be
2
clean. 4-603.14
3
Because of the variety of cleaning agents available and the many different
4
types of soil to be removed it is not possible to recommend one cleaning
5
agent to fit all situations. Each of the different types of cleaners works best
6
under different conditions (i.e., some work best on grease, some work best in
7
warm water, others work best in hot water). The specific chemical selected
8
should be compatible with any other chemicals to be used in the operation
9
such as a sanitizer or drying agent.
10
4-603.15
Wet Cleaning.
Washing, Procedures for Alternative Manual
Warewashing Equipment.
11
12
Some pieces of equipment are fixed or too large to be cleaned in a sink.
13
Nonetheless, cleaning of such equipment requires the application of cleaners
14
for the removal of soil and rinsing for the removal of abrasive and cleaning
15
chemicals, followed by sanitization.
4-603.16
16
Rinsing Procedures.
17
It is important to rinse off detergents, abrasive, and food debris after the wash
18
step to avoid diluting or inactivating the sanitizer.
4-603.17
19
Returnables, Cleaning for Refilling.*
20
The refilling of consumer-owned beverage containers introduces the possibility
21
of contamination of the filling equipment or product by improperly cleaned
22
containers or the improper operation of the equipment.
23
contamination and possible health hazards to the consumer, the refilling of
24
consumer-owned containers is limited to beverages that are not potentially
25
hazardous (time/temperature control for
26
designed to prevent the contamination of the equipment and means must be
27
provided to clean the containers at the facility.
28
Objective
29
Effective sanitization procedures destroy organisms of public health importance
30
that may be present on wiping cloths, food equipment, or utensils after cleaning,
4-701.10
To prevent this
safety) foods. Equipment must be
Food-Contact Surfaces and Utensils.
Guam Food Code Annex 1 – Public Health Reasons
196
1
or which have been introduced into the rinse solution. It is important that
2
surfaces be clean before being sanitized to allow the sanitizer to achieve its
3
maximum benefit.
4
Frequency 4-702.11
5
Sanitization is accomplished after the warewashing steps of cleaning and
6
rinsing so that utensils and food-contact surfaces are sanitized
7
coming in contact with food and before use.
8
Methods
9
Efficacious sanitization depends on warewashing being conducted within
10
certain parameters. Time is a parameter applicable to both chemical and hot
11
water sanitization. The time hot water or chemicals contact utensils or food-
12
contact surfaces must be sufficient to destroy pathogens that may remain on
13
surfaces after cleaning. Other parameters, such as rinse pressure, temperature,
14
and chemical
15
sanitization.
16
When surface temperatures of utensils passing through warewashing machines
17
using hot water for sanitizing do not reach the required 71ºC (160ºF), it is
18
important
19
temperature. A comparison should be made between the machine manufacturer‟s
20
operating instructions and the machine‟s actual wash and rinse temperatures and
21
final rinse pressure. The actual temperatures and rinse pressure should be
22
consistent with the machine manufacturer‟s operating instructions and within limits
23
specified in §§ 4-501.112 and 4-501.113.
24
If either the temperature or pressure of the final rinse spray is higher than the
25
specified upper limit, spray droplets may disperse and begin to vaporize
26
resulting
27
specified limit will not convey the needed heat to surfaces.
28
the specified
29
sanitizing rinse across utensil surfaces.
Before Use After Cleaning.*
4-703.11
before
Hot Water and Chemical.*
concentration are used in combination with time to achieve
to understand
the
factors
affecting
in less heat delivery to utensil surfaces.
limit will
the
decreased surface
Temperatures below the
Pressures below
result in incomplete coverage of the heat-conveying
Guam Food Code Annex 1 – Public Health Reasons
197
4-801.11
Clean Linens.
1
Objective
2
Linens that are not free from food residues and other soiling matter may
3
carry pathogenic microorganisms that may cause illness.
Frequency 4-802.11
4
Specifications.
5
Linens, cloth gloves, and cloth napkins are to be laundered between uses to
6
prevent the transfer of pathogenic microorganisms between foods or to food-
7
contact surfaces. The laundering of wet wiping cloths before being used with a
8
fresh solution of cleanser or sanitizer is designed to reduce the microbiological
9
load in the cleanser and sanitizer and thereby reduce the possible transfer of
10
microorganisms to food and nonfood-contact surfaces.
11
Methods
12
Soiled linens may directly or indirectly contaminate food. Proper storage will
13
reduce the possibility of contamination of food, equipment, utensils, and single-
14
service and single-use articles.
15
4-803.12
4-803.11
Storage of Soiled Linens.
Mechanical Washing.
16
Proper laundering of wiping cloths will significantly reduce the possibility that
17
pathogenic microorganisms will be transferred to food, equipment, or utensils.
4-803.13
18
Use of Laundry Facilities.
19
Washing and drying items used in the operation of the establishment on the
20
premises will help prevent the introduction of pathogenic microorganisms into
21
the environment of the food establishment.
22
Drying
23
Items must be allowed to drain and to air-dry before being stacked or stored.
24
Stacking wet items such as pans prevents them from drying and may allow an
25
environment
26
equipment and utensils is
27
microorganisms to equipment or utensils.
28
4-901.11
where
Equipment and Utensils, Air-Drying Required.
microorganisms
4-901.12
can begin
prohibited to
prevent
to
grow. Cloth drying of
the possible transfer of
Wiping Cloths, Air-Drying Locations.
29
Cloths that are air-dried must be dried so that they do not drip on food or
30
utensils and so that the cloths are not contaminated while air-drying.
Guam Food Code Annex 1 – Public Health Reasons
198
4-902.11
Food-Contact Surfaces.
1
Lubricating and
2
Reassembling
3
Food-contact surfaces must be lubricated in a manner that does not introduce
4
contaminants to those surfaces.
4-902.12
5
Equipment.
6
Equipment must be reassembled in a way that food-contact surfaces are not
7
contaminated.
8
Storing
4-903.11
Equipment, Utensils, Linens, and SingleService and Single-Use Articles.
9
10
Clean equipment and multiuse utensils which have been cleaned and
11
sanitized, laundered linens, and single-service and single-use articles can become
12
contaminated before their intended use in a variety of ways such as through
13
water leakage, pest infestation, or other insanitary condition.
14
4-903.12
Prohibitions.
15
The improper storage of clean and sanitized equipment, utensils, laundered
16
linens, and single-service and single-use articles may allow contamination before
17
their intended use. Contamination can be caused by moisture from absorption,
18
flooding, drippage, or splash.
19
materials, litter, dust, and other materials. The contamination is often related to
20
unhygienic employee practices, unacceptable high-risk storage locations, or
21
improper construction of storage facilities.
22
Preventing
4-904.11
Kitchenware and Tableware.
23
Contamination
4-904.12
Soiled and Clean Tableware.
4-904.13
Preset Tableware.
24
It can also
be caused by food debris, toxic
25
The presentation or setting of single-service and single-use articles and cleaned
26
and sanitized utensils shall be done in a manner designed to prevent the
27
contamination of food- and lip-contact surfaces.
28
29
Chapter 5 Water, Plumbing, and Waste
30
Source
5-101.11
Approved System.*
Guam Food Code Annex 1 – Public Health Reasons
199
1
Water, unless it comes from a
2
contamination for food, equipment, utensils, and hands. The major concern is that
3
water may become a vehicle for transmission of disease organisms. Water can
4
also become contaminated with natural or man-made chemicals. Therefore, for
5
the protection of consumers and employees, water must be obtained from a source
6
regulated by law and must be used, transported, and dispensed in a sanitary
7
manner.
5-101.12
8
safe
supply, may serve as a source of
System Flushing and Disinfection.*
9
During construction, repair, or modification, water systems may become
10
contaminated with microbes from soil because pipes are installed underground
11
or by chemicals resulting from soldering and welding. Floods and other
12
incidents may also cause water to
13
contaminants such as oils may also be present on or in the components of the
14
system. To render the water safe, the system must be properly flushed and
15
disinfected before being placed into service.
5-101.13
16
become
contaminated.
Chemical
Bottled Drinking Water.*
17
Bottled water is obtained from a public water system or from a private source
18
such as a spring or well. Either means of production must be controlled by public
19
health law to protect the consumer from contaminated water.
20
Quality
21
Bacteriological and chemical standards have been developed for public
22
drinking water supplies to protect public health. All drinking water supplies must
23
meet standards required by law.
24
5-102.11
Standards.*
5-102.12
Nondrinking Water.*
25
Food establishments may use nondrinking water for purposes such as air-
26
conditioning or fire protection.
27
bacteriological or chemical quality or safety as is drinking water. Consequently,
28
certain safety precautions must be observed to prevent the contamination of
29
food, drinking water, or food-contact surfaces. Identifying the piping designated
30
as nondrinking waterlines and inspection for cross connections are examples of
Nondrinking
water is not monitored for
Guam Food Code Annex 1 – Public Health Reasons
200
1
safety precautions.
5-102.13
2
Sampling.
3
Wells and other types of individual water supplies may become contaminated
4
through faulty equipment or
5
Periodic sampling is required by law to monitor the safety of the water and to
6
detect any change in quality. The controlling agency must be able to ascertain
7
that this sampling program is active and that the safety of the water is in
8
conformance with the appropriate standards.
9
accurate as the sample submitted. Care must be taken not to contaminate samples.
10
Proper sample collection and timely transportation to the laboratory are
11
necessary to ensure the safety of drinking water used in the establishment.
environmental contamination of ground water.
5-102.14
12
Laboratory results are only as
Sample Report.
13
The most recent water sampling report must be kept on file to document a
14
safe water supply.
15
Quantity and
16
Availability
17
Availability of sufficient water is a basic requirement for proper sanitation
18
within a food establishment. An insufficient supply of safe water will prevent
19
the proper cleaning of items such as equipment and utensils and of food
20
employees' hands.
21
Hot water required for washing items such as equipment and utensils and
22
employees' hands, must be available in sufficient quantities to meet demand
23
during peak water usage periods. Booster heaters for warewashers that use
24
hot water for sanitizing are designed to raise the temperature of hot water to a
25
level that ensures sanitization. If the volume of water reaching the booster
26
heater is not sufficient or hot enough, the required temperature for sanitization
27
can not be reached. Manual washing of food equipment and utensils is most
28
effective when hot water is used. Unless utensils are clean to sight and touch,
29
they cannot be effectively sanitized.
30
5-103.11
Capacity.*
5-103.12
Pressure.
Guam Food Code Annex 1 – Public Health Reasons
201
1
Inadequate water pressure could lead to situations that place the public health
2
at risk.
3
handwashing or equipment operation. Sufficient water pressure ensures that
4
equipment
5
manufacturer's specifications.
6
Distribution,
7
Delivery, and Retention
8
Inadequate water systems may serve as vehicles for contamination of food or
9
food- contact surfaces. This requirement is intended to ensure that sufficient
10
volumes of water are provided from supplies shown to be safe, through a
11
distribution system which is protected.
For
example,
such
as
inadequate
mechanical
pressure
warewashers
5-104.11
5-104.12
12
could
result in improper
operate according to
System.
Alternative Water Supply.
13
Water
from an approved source
14
conveyed. Improperly constructed and maintained water mains, pumps, hoses,
15
connections, and other appurtenances,
16
containers, may result in contamination of safe water and render it hazardous
17
to human health.
18
Materials
19
Plumbing systems and hoses conveying water must be made of approved
20
materials and be smooth, durable, nonabsorbent, and corrosion-resistant.
21
not, the system may constitute a health hazard because unsuitable surfaces
22
may harbor disease organisms or it may be constructed of materials that may,
23
themselves, contaminate the water supply.
24
Design,
25
Construction,
26
and Installation
27
Water within a system will leach minute quantities of materials out of the
28
components of the system. To make sure none of the leached matter is toxic
29
or in a form that may produce detrimental effects, even through long-term
30
use, all materials and components used in water systems must be of an
5-201.11
5-202.11
can
be
contaminated if inappropriately
as well as transport vehicles and
Approved.*
If
Approved System and Cleanable Fixtures.*
Guam Food Code Annex 1 – Public Health Reasons
202
1
approved type.
New or replacement items must be tested and approved
2
based on current standards.
3
Improperly designed, installed, or repaired water systems can have inherent
4
deficiencies such as improper access openings, dead spaces, and areas
5
difficult or impossible to clean and disinfect.
6
quality to degrade since
7
system. Fixtures such as warewashing sinks that are not easily cleanable
8
may lead to the contamination of food products.
9
5-202.12
Dead spaces allow water
they are out of the constant circulation of the
Handwashing Facility, Installation.
10
Warm water is more effective than cold water in removing the fatty soils
11
encountered in kitchens. An adequate flow of warm water will cause soap to
12
lather and aid in flushing soil quickly from the hands.
13
testing the efficacy of handwashing formulations specify a water temperature
14
of 40°C + 2°C (100 to 108°F).
15
An inadequate flow or temperature of water may lead to poor handwashing
16
practices by food employees. A mixing valve or combination faucet is needed
17
to provide properly tempered water for handwashing. Steam mixing valves
18
are not allowed for this use because they are hard to control and injury by
19
scalding is a possible hazard.
20
5-202.13
ASTM Standards for
Backflow Prevention, Air Gap.*
21
During periods of extraordinary demand, drinking water systems may develop
22
negative pressure in portions of the system. If a connection exists between the
23
system and a source of contaminated water during times of negative pressure,
24
contaminated water may be drawn into and foul the entire system. Standing
25
water in sinks, dipper wells, steam kettles, and other equipment may become
26
contaminated with cleaning chemicals
27
introduction of this liquid into the water supply through back siphonage, various
28
means may be used.
or
food residue.
Guam Food Code Annex 1 – Public Health Reasons
203
To
prevent
the
1
The water outlet of a drinking water system must not be installed so that it
2
contacts water in sinks, equipment, or other fixtures that use water. Providing an
3
air gap between the water supply outlet and the flood level rim of a plumbing
4
fixture or equipment prevents contamination that may be caused by backflow.
5-202.14
5
Backflow Prevention Device, Design Standard.
6
In some instances an air gap is not practical such as is the case on the lower
7
rinse arm for the final rinse of warewashers. This arm may become submerged if
8
the machine drain becomes clogged. If this failure occurs, the machine tank would
9
fill to the flood level rim, which is above the rinse arm. A backflow prevention
10
device is used to avoid potential backflow of contaminated water when an air
11
gap is not practical. The device provides a break to the atmosphere in the
12
event of a negative pressure within the system. Minerals contained in water and
13
solid particulate matter carried in water may coat moving parts of the device
14
or become lodged between them over time.
15
inoperative.
16
standards of construction, installation, maintenance, inspection, and testing for
17
that application may be used. The necessary maintenance can be facilitated by
18
installing these devices in accessible locations.
This may render the device
To minimize such an occurrence, only devices meeting certain
5-202.15
19
Conditioning Device, Design.
20
Water conditioning devices must be designed for easy disassembly for
21
servicing so that they can be maintained in a condition that allows them to
22
perform the function for which they were designed.
23
Numbers and
24
Capacities
25
Because
26
foodborne illness, sufficient facilities must be available to make handwashing
27
not only possible, but likely.
28
5-203.11
handwashing
is
Handwashing Facilities.*
such an
5-203.12
important
factor in the prevention of
Toilets and Urinals.*
29
Adequate, sanitary toilet facilities are necessary for the proper disposal of
30
human waste, which carries pathogenic microorganisms, and for preventing
Guam Food Code Annex 1 – Public Health Reasons
204
1
the spread of disease by flies and other insects.
2
Toilet facilities must be of sanitary design and kept clean and in good repair to
3
prevent
4
practices in the establishment.
food
contamination
and to motivate employees to use sanitary
5-203.13
5
Service Sink.
6
Mop water and similar liquid wastes are contaminated with microorganisms
7
and other filth. Waste water must be disposed of in a sanitary manner that
8
will not contaminate food or food equipment.
9
cleaning facility with a drain allows for such disposal.
5-203.14
10
A service sink or curbed
Backflow Prevention Device, When Required.*
11
The delivery end of hoses attached to hose bibbs on a drinking water line
12
may be dropped into containers filled with contaminated water or left in
13
puddles on the floor or in other possible sources of contamination. A backflow
14
prevention device must be installed on the hose bibb to prevent
15
siphonage of
16
occasional periods of negative pressure in the water line.
contaminated liquid
5-203.15
17
into the drinking
water
the
back
system during
Backflow Prevention Device, Carbonator.*
18
When carbon dioxide is mixed with water, carbonic acid, a weak acid, is
19
formed.
20
Carbonators on soft drink dispensers form such acids as they carbonate the
21
water to be mixed with the syrups to produce the soft drinks.
22
dioxide backs up into a copper water line, carbonic acid will dissolve some
23
of the copper. The water containing the dissolved copper will subsequently
24
be used in dispensing soft drinks and the first few customers receiving the
25
drinks are likely to suffer with the symptoms of copper poisoning.
26
An air gap or a vented backflow prevention device meeting ASSE Standard
27
No. 1022 will prevent this occurrence, thereby reducing incidences of copper
28
poisoning.
Guam Food Code Annex 1 – Public Health Reasons
205
If carbon
5-204.11
Handwashing Sinks.*
1
Location and
2
Placement
3
Hands are probably
4
pathogens
5
variety of contaminants during routine operations.
6
unlikely to wash their hands unless properly equipped handwashing facilities
7
are accessible in the immediate work area. Facilities which are improperly
8
located may be blocked by portable equipment or stacked full of soiled utensils
9
and other items, rendering the facility unavailable for regular employee use.
the most
common vehicle
for
the
transmission
of
to foods in an establishment. Hands can become soiled with a
must
block
10
Nothing
11
discouraging its use, and the facility must be kept clean and well stocked
12
with soap and sanitary towels to encourage frequent use.
5-204.12
13
the
approach
to
a
Some employees are
handwashing facility thereby
Backflow Prevention Device, Location.
14
Backflow prevention devices are meant to protect the drinking water system
15
from contamination caused
16
prevention devices will not work. If inconveniently located, these devices
17
may not be accessed when systems are extended, altered, serviced, or
18
replaced. Over a period of time, unserviced devices may fail and system
19
contamination may occur.
20
5-204.13
21
When not located
22
inconvenient to access and devices such as filters, screens, and water
23
softeners will become clogged because they are not properly serviced.
24
Operation and
25
Maintenance
26
Facilities must be maintained in a condition that promotes handwashing and
27
restricted for that use.
28
encourages timely handwashing which provides a break in the chain of
29
contamination from the hands of
30
surfaces. Sinks used for food preparation and warewashing can become
by
backflow.
If
improperly placed, backflow
Conditioning Device, Location.
for easy
5-205.11
maintenance, conditioning
devices will be
Using a Handwashing Sink.
Convenient accessibility of a handwashing facility
food
employees
to food or food-contact
Guam Food Code Annex 1 – Public Health Reasons
206
1
sources of contamination if used
2
returning from the toilet or from duties which have contaminated their hands.
5-205.12
3
as
handwashing
facilities by employees
Prohibiting a Cross Connection.*
4
Nondrinking water may be of unknown or questionable origin. Waste water is
5
either known or suspected to be contaminated. Neither of these sources can be
6
allowed to contact and contaminate the drinking water system.
7
5-205.13
8
Water system devices, such as filters and backflow preventers, are affected by
9
the water in the system. How devices are affected depends on water quality,
Scheduling Inspection and Service for a Water System Device.
10
especially pH, hardness, and
11
Complexity of the device is also a factor. Manufacturer recommendations, as
12
well as inspection and maintenance schedules for these devices, must be
13
strictly followed to prevent failure during operation.
14
Cleaning
5-205.14
suspended particulate matter in the water.
Water Reservoir of Fogging
Devices, Cleaning.*
15
16
Water reservoirs that have poor water exchange rates, such as reservoirs for
17
some humidifiers or aerosol or fogging devices, and that are directly or
18
indirectly open to the atmosphere, may be contaminated with respiratory
19
pathogens such as Legionella pneumophila. This organism is extremely
20
infectious and can be transmitted through very small droplets of a fogger or
21
humidifier.
22
schedule be scrupulously followed to prevent a reservoir from colonization by
23
this bacterium.
It is important that the manufacturer's cleaning and maintenance
5-205.15
24
System Maintained in Good Repair.*
25
Improper repair or maintenance of any portion of the plumbing system may
26
result
27
leakage. These conditions may result in the contamination of food, equipment,
28
utensils, linens, or single-service or single-use articles.
29
maintenance may result in the creation of obnoxious odors or nuisances, and
30
may also adversely affect the operation of warewashing equipment or other
in potential health hazards such as cross connections, backflow, or
Guam Food Code Annex 1 – Public Health Reasons
207
Improper repair or
1
equipment which depends on sufficient
2
intended functions.
3
Materials
4
Materials used in the construction of a mobile water tank are affected by the
5
water they contact. Tank liners may deteriorate and flake. Metals or platings
6
can be toxic. To prevent the degradation of the quality of the water, it is
7
important that the materials used in the construction of the tank are suitable
8
for such use.
9
Design and
5-302.11
Enclosed System, Sloped to Drain.
Construction
5-302.12
Inspection and Cleaning Port, Protected and
10
5-301.11
volume and pressure to perform its
Approved.
Secured.
11
12
The tank must be a closed system from the filling inlet to the outlet to
13
prevent contamination of water. It is important that the bottom of the tank be
14
sloped to the outlet to allow the tank to drain completely, to facilitate the
15
proper cleaning and disinfection of the tank, and to prevent the retention of
16
water or solutions after cleaning.
17
Some tanks are designed with an access opening to facilitate the cleaning and
18
servicing of the water tank. The access must be constructed to prevent the
19
opening from becoming a source of contamination of the water.
5-302.13
20
“V” Type Threads, Use Limitation.
21
V-type threads are difficult to clean if contaminated with food or waste. To
22
prevent the contamination of the drinking water, this type of thread should
23
only be used on
24
permanent which eliminates exposed, difficult-to-clean threads.
25
5-302.14
26
Water tanks are equipped with a vent to preclude distortion during filling or
27
draining. The vent should be equipped with a suitable screen or filter to
28
protect
29
contaminate the water supply.
30
water tank inlets and outlets if
the connection is
Tank Vent, Protected.
the
tank against
5-302.15
the
entry
of insects or other vermin that may
Inlet and Outlet, Sloped to Drain.
Guam Food Code Annex 1 – Public Health Reasons
208
1
Both the inlet and outlet must be sloped to drain to prevent the pooling of
2
possibly contaminated water or sanitizing solution.
3
5-302.16
Hose, Construction and Identification.
4
Hoses used to fill potable water tanks should be dedicated for that one task
5
and should be identified
6
water. Hoses must be made of a material that will not leach detrimental
7
substances into the water.
8
Numbers and
9
Capacities
for that use only to prevent contaminating the
5-303.11
Filter, Compressed Air.
10
Compressor pistons are lubricated with oil to minimize wear. Some of the oil
11
is carried into the air lines and if not intercepted may contaminate the tank
12
and water lines.
5-303.12
13
Protective Cover or Device.
14
Protective equipment provided for openings of the water supply must be in
15
use to prevent contamination which may be present where the supply is
16
exposed to the environment, i.e., at water inlets or outlets or the ends of
17
transfer hoses.
18
5-303.13
Mobile Food Establishment Tank Inlet.
19
Mobile units may be particularly vulnerable to environmental contamination if
20
soiled hose connections are coupled to the tank inlet.
21
Operation and
22
Maintenance
23
Contaminants of various types may be introduced into a water system during
24
construction or repair or
25
sanitized after maintenance and before it is placed into service to prevent
26
contamination of the water introduced into the tank.
5-304.11
System Flushing and Disinfection.*
other incidents. The system must be flushed and
Guam Food Code Annex 1 – Public Health Reasons
209
5-304.12
1
Using a Pump and Hoses, Backflow Prevention.
2
When a water system includes a pump, or a pump is used in filling a water
3
tank, care must be taken during hookup to prevent negative pressure on the
4
supplying water system.
5
especially necessary during cleaning and sanitizing operations on a mobile
6
system.
5-304.13
7
Backflow prevention to protect the water supply is
Protecting Inlet, Outlet, and Hose Fitting.
8
When not connected for use, water inlets, outlets, and hose fittings should be
9
closed to the environment. Unless capped or otherwise protected, filling inlets,
10
outlets, and hoses may become contaminated by dust or vermin.
5-304.14
11
Tank, Pump, and Hoses, Dedication.
12
Hoses, pumps, and tanks used for food or water may not be used for other
13
liquids because this may contaminate the water supply. If a hose, tank, or pump
14
has been used to transfer liquid food, the equipment must be cleaned and
15
sanitized before using it for water delivery. Failure to properly clean and sanitize
16
the equipment would introduce nutrients, and possibly bacteria, into the water
17
as well as inactivate residual chlorine from public water supplies.
18
Mobile
5-401.11
Capacity and Drainage.
Guam Food Code Annex 1 – Public Health Reasons
210
1
Holding Tank
2
Liquid waste from a mobile or temporary food establishment must be stored
3
in a properly constructed waste tank to discourage the attraction of flies and
4
other vermin. The waste tank must be 15% larger than the water storage
5
tank to allow for storage of wastes and used water from the drinking water
6
supply tank. The drain from the waste tank must be larger than the filling
7
hose to prevent the use of the drinking water filling hose to drain the waste
8
tank.
9
Retention,
5-402.10
Establishment Drainage System.
10
Drainage, and
11
Delivery
12
The drainage system must be designed and installed properly to prevent the
13
backup of sewage and the
14
surfaces in the establishment.
possible contamination of foods or food-contact
5-402.11
15
Backflow Prevention.*
16
Improper plumbing installation or maintenance may result in potential health
17
hazards such as cross connections,
18
conditions may result in the contamination of food, utensils, equipment, or other
19
food-contact surfaces. It may also adversely affect the operation of equipment
20
such as warewashing machines.
21
The exception in paragraph 5-402.11(B) allows for a direct connection to the
22
sanitary sewer system for floor drains originating in refrigerated spaces that
23
are constructed as an integral part of the building structure. Examples of
24
refrigerated spaces that are considered an integral part of the building include
25
refrigerated prep rooms, meat cutting rooms, and refrigerated storage rooms.
26
The exception specifically targets refrigerated spaces that are considered an
27
integral part of the
28
refrigerators and freezers with prefabricated floors. It is not intended to apply
29
to pieces of equipment, including those which may be located in a
building.
back siphonage or backflow.
It does
not apply to
Guam Food Code Annex 1 – Public Health Reasons
211
These
prefabricated walk-in
1
refrigerated room and which indirectly drain to a floor drain within the room.
2
Drainage from equipment is addressed under paragraph 5-402.11(A).
5-402.12
3
Grease Trap.
4
Failure to locate a grease trap so that it can be properly maintained and
5
cleaned could result in the harborage of vermin and/or the failure of the
6
sewage system.
7
5-402.13
Conveying Sewage.*
8
5-402.14
Removing Mobile Food Establishment Waste.
9
Improper disposal of waste provides
a potential for contamination of food,
10
utensils, and equipment and, therefore, may cause serious illness or disease
11
outbreaks.
12
surfaces and water supplies, or creation of other insanitary conditions that may
13
attract insects and other vermin.
Proper removal
5-402.15
14
is required to prevent contamination of ground
Flushing a Waste Retention Tank.
15
Thoroughly flushing the liquid waste retention tank will prevent the buildup of
16
deposits within the tank which could affect the proper operation of the tank.
17
Disposal
18
Facility
19
Many diseases can be transmitted from one person to another through fecal
20
contamination of food and water. This transmission can be indirect. Proper
21
disposal of human wastes greatly reduces the risk of fecal contamination. This
22
Code provision is intended to ensure that wastes will not contaminate ground
23
surfaces or water supplies; pollute surface waters; be accessible to children or
24
pets; or allow rodents or insects to serve as vectors of disease from this
25
source.
5-403.11
5-403.12
26
Approved Sewage Disposal System.*
Other Liquid Waste and Rainwater.
27
Liquid food
wastes and
28
contamination and support populations of pests. Proper storage and disposal
29
of wastes and drainage of rainwater eliminate these conditions.
30
Facilities
5-501.10
rainwater
can
provide a
Indoor Storage Area.
Guam Food Code Annex 1 – Public Health Reasons
212
source of bacterial
1
on
5-501.11
Outdoor Storage Surface.
2
the Premises
5-501.12
Outdoor Enclosure.
3
5-501.13
Receptacles.
4
5-501.14
Receptacles in Vending Machines.
5
5-501.15
Outside Receptacles.
6
5-501.16
Storage Areas, Rooms, and Receptacles,
Capacity and Availability.
7
8
5-501.17
Toilet Room Receptacle, Covered.
9
5-501.18
Cleaning Implements and Supplies.
10
5-501.19
Storage
Areas,
Redeeming
Machines,
11
Receptacles and Waste Handling Units,
12
Location.
13
5-501.110
Refuse,
Recyclables,
and
Returnables.
14
15
Storage
5-501.111
Areas, Enclosures, and Receptacles, Good
Repair.
16
17
5-501.112
Outside Storage Prohibitions.
18
5-501.113
Covering Receptacles.
19
5-501.114
Using Drain Plugs.
20
5-501.115
Maintaining Refuse Areas and Enclosures.
21
5-501.116
Cleaning Receptacles.
22
Proper storage and disposal of garbage and refuse are necessary to minimize
23
the development of odors, prevent such waste from becoming an attractant
24
and harborage or breeding place for insects and rodents, and prevent the soiling
25
of food preparation and food service areas. Improperly handled garbage
26
creates nuisance conditions, makes housekeeping difficult, and may be a
27
possible source of contamination of food, equipment, and utensils.
28
Storage areas for garbage and refuse containers must be constructed so that
29
they can be thoroughly cleaned in order to avoid creating an attractant or
Guam Food Code Annex 1 – Public Health Reasons
213
1
harborage for insects or rodents. In addition, such storage areas must be
2
large enough to accommodate all the containers necessitated by the operation
3
in order to prevent scattering of the garbage and refuse.
4
All containers must be maintained in good repair and cleaned as necessary
5
in order to store garbage and refuse under sanitary conditions as well as to
6
prevent the breeding of flies.
7
Garbage containers should be available wherever garbage is generated to
8
aid in the proper disposal of refuse.
9
Outside receptacles must be constructed with tight-fitting lids or covers to
10
prevent the scattering of the garbage or refuse by birds, the breeding of flies,
11
or the entry of rodents. Proper equipment and supplies must be made
12
available to accomplish thorough and proper cleaning of garbage storage
13
areas and receptacles so that unsanitary conditions can be eliminated.
14
Removal
15
5-502.11
Frequency.
5-502.12
Receptacles or Vehicles.
16
Refuse, recyclables, and returnable items, such as beverage cans and
17
bottles, usually contain a residue of the original contents. Spillage from these
18
containers soils receptacles and storage areas and becomes an attractant for
19
insects, rodents, and other pests. The handling of these materials entails
20
some of the same problems and solutions as the handling of garbage and
21
refuse. Problems are minimized when all of these materials are removed from
22
the premises at a reasonable frequency.
23
Facilities
24
for Disposal
25
and Recycling
26
Alternative means of solid waste disposal must be conducted properly to
27
prevent environmental consequences and the attraction of insects, rodents, and
28
other pests.
5-503.11
Community or Individual Facility.
29
30
Chapter 6 Physical Facilities
Guam Food Code Annex 1 – Public Health Reasons
214
6-101.11
Surface Characteristics.
1
Indoor Areas
2
Floors, walls, and ceilings that are constructed of smooth and durable surface
3
materials are more easily cleaned.
4
Floor surfaces that are graded to drain and consist of effectively treated
5
materials will prevent contamination of foods from dust and organisms from
6
pooled moisture.
7
The special requirements for carpeting materials and nonabsorbent materials in
8
areas subject to moisture are intended to ensure that the cleanability of these
9
surfaces is retained.
10
Although food served from temporary food establishments is subject to the same
11
potential for contamination as food served in permanent establishments, the
12
limited capabilities and short duration of operation are recognized by less stringent
13
requirements for surface characteristics.
14
Outdoor Areas
15
The requirements concerning surface
16
intended to facilitate maintenance and minimize the accumulation of dust and
17
mud on walking and driving areas, provide durable exterior building surfaces,
18
and prevent the attracting, harboring, or breeding of insects, rodents, and
19
other pests where refuse, recyclables, or returnables are stored.
20
Cleanability
21
6-102.11
Surface Characteristics.
characteristics
of outdoor areas are
6-201.11
Floors, Walls, and Ceilings.
6-201.12
Floors, Walls, and Ceilings, Utility Lines.
22
Floors that are of smooth, durable construction and that are nonabsorbent are
23
more easily cleaned. Requirements and restrictions regarding floor coverings,
24
utility lines, and floor/wall junctures are intended to ensure that regular and
25
effective cleaning is possible and that insect and rodent harborage is minimized.
26
6-201.13
Floor and Wall Junctures, Coved, and Enclosed or Sealed.
27
When cleaning is accomplished by spraying or flushing, coving and sealing of
28
the floor/wall junctures is required to provide a surface that is conducive to
29
water flushing.
Guam Food Code Annex 1 – Public Health Reasons
215
1
Grading of the floor to drain allows liquid wastes to be quickly carried away,
2
thereby preventing pooling which could attract pests such as insects and
3
rodents or contribute to problems with certain pathogens such as Listeria
4
monocytogenes.
5
6-201.14
Floor Carpeting, Restrictions and Installation.
6
Requirements and restrictions regarding floor carpeting are intended to ensure
7
that regular and effective cleaning is possible and that insect harborage is
8
minimized. The restrictions for areas not
9
designed to ensure cleanability of surfaces where accumulation of moisture or
10
suited for carpeting materials are
waste is likely.
6-201.15
11
Floor Covering, Mats and Duckboards.
12
Requirements regarding mats and duckboards are intended to ensure that
13
regular and effective cleaning is possible and that accumulation of dirt and
14
waste is prevented.
15
6-201.16
Wall and Ceiling Coverings and Coatings.
16
6-201.17
Walls and Ceilings, Attachments.
17
6-201.18
Walls and Ceilings, Studs, Joists, and Rafters.
18
Walls and ceilings that are of smooth construction, nonabsorbent, and in good
19
repair can be easily and effectively cleaned. Special requirements related to the
20
attachment of accessories and exposure of wall and ceiling studs, joists, and
21
rafters are intended to ensure the cleanability of these surfaces.
22
Functionality
23
Shielding of light bulbs helps prevent breakage. Light bulbs that are shielded,
24
coated, or otherwise shatter-resistant are necessary to protect exposed food,
25
clean equipment, utensils and linens, and unwrapped single-service and single-
26
use articles from glass fragments should the bulb break.
27
6-202.12
6-202.11
Light Bulbs, Protective Shielding.
Heating, Ventilating, Air Conditioning System Vents.
Guam Food Code Annex 1 – Public Health Reasons
216
1
Heating and air conditioning system vents that are not properly designed and
2
located may be difficult to clean and result in the contamination of food, food
3
preparation surfaces, equipment, or utensils by dust or other accumulated soil
4
from the exhaust vents.
5
6-202.13
Insect Control Devices, Design and Installation.
6
Insect electrocution devices are considered supplemental to good sanitation
7
practices in meeting the Code requirement for controlling the presence of flies
8
9
and other insects in a food establishment.
10
Improper design of the device and dead insect collection tray could allow dead
11
insect parts and injured insects to escape, rendering the device itself a
12
source of contamination.
13
Exposed
14
contamination by insects or insect parts. Installation of the device over food
15
preparation areas or in close proximity to exposed food and/or food-contact
16
surfaces could allow dead insects and/or insect parts to be impelled by the
17
electric charge, fall, or be blown from the device onto food or food-contact
18
surfaces.
19
food
and
food-contact
6-202.14
surfaces
must
be
protected
from
Toilet Rooms, Enclosed.
20
Completely enclosed toilet facilities minimize the potential for the spread of
21
disease by the movement of flies and other insects between the toilet facility
22
and food preparation areas.
23
6-202.15
Outer Openings, Protected.
24
Insects and rodents are vectors of disease-causing microorganisms which may
25
be transmitted to humans by contamination of food and food-contact surfaces.
26
The presence of insects and rodents is minimized by protecting outer
27
openings to the food establishment.
28
In the National Fire Protection Association‟s NFPA 101, Life Safety Code,
29
2003 Edition, doors to exit enclosures such as stairs, horizontal exits, or exit
Guam Food Code Annex 1 – Public Health Reasons
217
1
passageways are required to be self closing. The Life Safety Code does not
2
require exterior doors used as exits to be self closing, but they can be.
3
The intent of subparagraph 6-202.15(A)(3) is to protect food establishments
4
from the entry of insects and rodents by keeping doors closed when not in
5
use. Self-closing devices allow a door to return to its closed position after use. If
6
an exterior door is not routinely used for entry or exit because its use is restricted
7
by the fire protection authority for emergency use only, it is not a portal for the
8
entry of pests and does not need a self-closing device. Doors not requiring a
9
self-closing device include exterior emergency exit doors that open into a public
10
11
way from a fire and that meet the criteria in ¶ 6-202.15(C).
6-202.16
Exterior Walls and Roofs, Protective Barrier.
12
Walls and roofs provide a barrier to protect the interior and foods from the
13
weather, windblown dirt and debris, and flying insects.
14
6-202.17
Outdoor Food Vending Areas, Overhead Protection.
15
The potential for contamination from airborne dust and particulates or
16
inclement weather is present in outside areas. Overhead protection minimizes
17
the potential for contamination of food under such conditions.
18
6-202.18
Outdoor Servicing Areas, Overhead Protection.
19
Pooled water, which may result if overhead protection is not provided for
20
outdoor servicing areas, attracts wild animals and birds and creates a
21
condition suitable for the breeding of insects.
22
6-202.19
23
If foot traffic is allowed to occur from undrained areas, contamination will be
24
tracked into the establishment.
25
conditions. Pooled water on exterior walking and driving surfaces may also
26
attract rodents and breed insects.
27
Outdoor Walking and Driving Surfaces, Graded to Drain.
6-202.110
Surfaces graded to drain minimize these
Outdoor Refuse Areas, Curbed and Graded to Drain.
28
If refuse areas are not graded properly, waste water will pool and attract
29
insects and rodents.
Guam Food Code Annex 1 – Public Health Reasons
218
1
6-202.111
Private Homes and Living or Sleeping Quarters, Use Prohibited.
6-202.112
2
Living or Sleeping Quarters, Separation.
3
Areas or facilities that are not compatible with sanitary food establishment
4
operations must be located or separated from other areas of the establishment
5
to preclude potential contamination of food and food-contact surfaces from
6
poisonous or toxic materials, dust or debris, the presence of improperly
7
designed facilities and equipment, and the traffic of unauthorized and/or
8
unnecessary persons or pets.
9
Further, Article IV of the Amendments to the U.S. Constitution ensures the
10
right of persons to be secure in their homes against unreasonable search and
11
seizure. This provision could hinder the regulatory authority's access to
12
conduct routine inspections of a food establishment operated in the living area
13
of a private home. A search warrant may be the only mechanism by which to
14
gain entry; yet, it may be difficult to obtain and might not authorize the
15
necessary inspectional activities.
16
Handwashing
17
Sinks
18
Refer to the public health reason for § 5-203.11.
19
6-301.10
6-301.11
Minimum Number.
Handwashing Cleanser, Availability.
20
Hand cleanser must always be present to aid in reducing microorganisms and
21
particulate matter found on hands.
22
6-301.12
Hand Drying Provision.
23
Provisions must be provided for hand drying so that employees will not dry their
24
hands on their clothing or other unclean materials.
25
6-301.14
Handwashing Signage.
Guam Food Code Annex 1 – Public Health Reasons
219
1
A sign or poster is required to remind food employees to wash their hands.
6-301.20
2
Disposable Towels, Waste Receptacle.
3
Waste receptacles at handwashing sinks are required for the collection of
4
disposable towels so that the paper waste will be contained, will not contact
5
food directly or indirectly, and will not become an attractant for insects or
6
rodents.
7
Toilets and
8
Urinals
9
Refer to the public health reason for § 5-203.12.
10
6-302.11
6-302.10
Minimum Number.
Toilet Tissue, Availability.
11
To minimize hand contact with fecal
12
hygienic cleaning following use of toilet facilities. Toilet tissue must be
13
supplied to meet the demand.
14
Lighting
15
Lighting levels are specified so that
16
employees to perform certain functions such as reading labels; discerning the
17
color of substances; identifying toxic materials; recognizing the condition of
18
food, utensils, and supplies; and safely conducting general food establishment
19
operations and clean-up. Properly distributed light makes the need for cleaning
20
apparent by making accumulations of soil conspicuous.
21
Ventilation 6-304.11
22
When mechanical ventilation is necessary, it must have adequate capacity to
23
ensure that soiling of walls, ceilings,
24
obnoxious odors or toxic fumes are effectively removed; and no hazards or
25
nuisances involving accumulation of fats, oils, and similar wastes are created.
26
Balancing of the exhaust and make-up air must be ensured so that the system
27
can operate efficiently.
6-303.11
waste, toilet tissue is necessary for
Intensity.
sufficient
light is available to enable
Mechanical.
and
other
equipment
Guam Food Code Annex 1 – Public Health Reasons
220
is minimized;
6-305.11
Designation.
1
Dressing Areas
2
and Lockers
3
Street clothing and personal belongings can contaminate food, food equipment,
4
and food-contact surfaces. Proper storage facilities are required for articles such
5
as purses, coats, shoes, and personal medications.
6
Service Sinks
7
A service sink or curbed facility is required so that the cleanliness of the food
8
establishment can be maintained, attractants for insects and rodents minimized,
9
and contamination of food and equipment by accumulated soil prevented.
10
Liquid wastes generated during cleaning must be disposed of in a sanitary
11
manner to preclude contamination of food and food equipment.
12
sink is provided to prevent the improper disposal of wastes into other sinks
13
such as food preparation and handwashing sinks.
14
Handwashing
15
Sinks
16
Facilities must be located in or adjacent to toilet rooms and convenient to the
17
different
18
handwashing to prevent contamination of the food and food-contact surfaces.
19
Toilet Rooms
20
Toilet rooms must be conveniently accessible to food employees at all times to
21
encourage employee use of appropriate facilities for the disposing of human
22
wastes as needed followed by the washing of hands.
23
Employee
24
Accommodations
25
Because employees could introduce pathogens to food by hand-to-mouth-to-
26
food contact and because
27
contaminants, areas designated to accommodate employees' personal needs
28
must be carefully located. Food, food equipment and utensils, clean linens, and
29
single-service and single-use articles must not be in jeopardy of contamination
30
from these areas.
6-306.10
6-401.10
work stations of
Availability.
A service
Conveniently Located.
the
food
6-402.11
6-403.11
employee for proper
routine
Convenience and Accessibility.
Designated Areas.
street clothing
and personal
Guam Food Code Annex 1 – Public Health Reasons
221
and
belongings carry
1
Distressed 6-404.11
Segregation and Location.
2
Merchandise
3
Products which are damaged, spoiled, or otherwise unfit for sale or use in a
4
food establishment may become mistaken for safe and wholesome products and/or
5
cause contamination of other foods, equipment, utensils, linens, or single-
6
service or single-use articles. To preclude this, separate and segregated
7
areas must be designated for storing unsalable goods.
8
Refuse,
9
Recyclables,
6-405.10
Receptacles, Waste Handling Units, and
Designated Storage Areas.
10
and Returnables
11
Waste materials and empty product
12
attractant to insects and rodents. Food, equipment, utensils, linens, and single-
13
service and single-use articles must be protected from exposure to filth and
14
unclean conditions and other contaminants. This Code provision addresses
15
these concerns by requiring the facility to be segregated, to be located to allow
16
cleaning of adjacent areas, and to preclude creation of a nuisance.
17
Premises,
18
Structures,
19
Attachments,
20
and Fixtures,
21
- Methods
22
Poor repair and maintenance compromises
23
facilities. This requirement is intended to ensure that the physical facilities are
24
properly maintained in order to serve their intended purpose.
25
6-501.11
6-501.12
containers are unclean and can be an
Repairing.
the functionality of the physical
Cleaning, Frequency and Restrictions.
26
Cleaning of the physical facilities is an
important
measure in ensuring the
27
protection and sanitary preparation of food. A regular cleaning schedule should
28
be established and followed to maintain the facility in a clean and sanitary
29
manner. Primary cleaning should be done at times when foods are in protected
30
storage and when food is not being served or prepared.
Guam Food Code Annex 1 – Public Health Reasons
222
6-501.13
1
Cleaning Floors, Dustless Methods.
2
Dustless floor cleaning methods must be used so that food; equipment,
3
utensils, and linens; and single-service and single-use articles are not
4
contaminated.
5
6-501.14
Cleaning Ventilation Systems, Nuisance and Discharge
Prohibition.
6
7
Both intake and exhaust ducts can be a source of contamination and must be
8
cleaned regularly. Filters that collect particulate matter must be cleaned or changed
9
frequently to prevent overloading of the filter. Outside areas under or adjacent to
10
exhaust duct outlets at the exterior of the building must be maintained in a clean
11
and sanitary manner to prevent pest attraction.
12
6-501.15
13
Maintenance tools used to repair the physical facilities must be cleaned in a
14
separate area to prevent contamination of food and food preparation and
15
warewashing areas.
Cleaning Maintenance Tools, Preventing Contamination.*
6-501.16
16
Drying Mops.
17
Mops can contaminate food and food preparation areas if not properly cleaned
18
and stored after use. Mops should be cleaned and dried in a sanitary manner
19
20
21
away from food flow areas.
6-501.17
Absorbent Materials on Floors, Use Limitation.
22
Cleanliness of the food establishment is important to minimize attractants for
23
insects
24
equipment
25
and prevent nuisance conditions. A clean and orderly food establishment is
26
also conducive to positive employee
27
attention to personal hygiene and improved food preparation practices. Use of
28
specified cleaning procedures is important in precluding avoidable contamination
29
of food and equipment and nuisance conditions.
and
rodents,
aid
in preventing the
contamination of
and
attitudes which can lead to increased
Guam Food Code Annex 1 – Public Health Reasons
223
food
1
Temporary floor coverings such as sawdust can contaminate food, attract
2
insects and rodents, and become a nuisance to the food operation.
6-501.18
3
Maintaining and Using Handwashing Sinks.
4
Handwashing facilities are critical to food protection and must be maintained
5
in operating order at all times so they will be used.
6
Refer also to the public health reason for § 5-205.11.
6-501.19
7
Closing Toilet Room Doors.
8
Toilet room doors must remain closed except during cleaning operations to
9
prevent insect and rodent entrance and the associated potential for the
10
spread of disease.
6-501.110
11
clothing
and
Using Dressing Rooms and Lockers.
12
Street
personal
13
equipment, and food preparation surfaces and consequently must be stored
14
in properly designated areas or rooms.
6-501.111
15
belongings can
contaminate
food,
food
Controlling Pests.*
16
Insects and other pests are capable of transmitting disease to man by
17
contaminating food and food-contact surfaces. Effective measures must be taken
18
to control their presence in food establishments.
19
6-501.112
20
Removing Dead or Trapped Birds, Insects, Rodents, and Other
Pests.
21
Dead rodents, birds, and insects must be removed promptly from the facilities
22
to ensure clean and sanitary facilities and to preclude exacerbating the
23
situation by allowing carcasses to attract other pests.
24
6-501.113
Storing Maintenance Tools.
25
Brooms, mops, vacuum cleaners, and
other maintenance equipment can
26
contribute contamination to food and food-contact surfaces. These items must
27
be stored in a manner that precludes such contamination.
28
To prevent harborage and breeding
29
maintenance equipment must be stored in an orderly fashion to permit
30
cleaning of the area.
conditions for rodents and insects,
Guam Food Code Annex 1 – Public Health Reasons
224
6-501.114
1
Maintaining Premises, Unnecessary Items and Litter.
2
The presence of unnecessary articles, including equipment which is no longer
3
used, makes regular and effective cleaning more difficult and less likely. It can
4
also provide harborage for insects and rodents.
5
Areas designated as equipment storage areas and closets must be maintained
6
in a neat, clean, and sanitary manner. They must be routinely cleaned to avoid
7
attractive or harborage conditions for rodents and insects.
6-501.115
8
Prohibiting Animals.*
9
Animals carry disease-causing organisms and can transmit pathogens to humans
10
through direct and/or indirect contamination of food and food-contact surfaces.
11
The restrictions apply to live animals with limited access allowed only in
12
specific situations and under controlled conditions and to the storage of live and
13
dead fish bait. Employees with service animals are required under § 2-301.14
14
to wash their hands after each contact with animals to remove bacteria and
15
soil.
16
Animals shed hair continuously and may deposit liquid or fecal waste,
17
creating the need for vigilance and
18
efforts.
19
The definition for
20
pursuant to the Americans with Disabilities Act (ADA) of 1990 (42 U.S.C. 12101
21
et seq.). A service animal performs some of the functions that persons with a
22
disability cannot perform for themselves, such as those provided by “seeing
23
eye dogs”; alerting persons with hearing impairments to sounds; pulling
24
wheelchairs
25
impairments; and assisting persons with mobility impairments with balance. A
26
service animal is not considered to be a pet.
27
Under Title III of the ADA, privately owned businesses that serve the public are
28
prohibited from discriminating
29
requires these businesses to allow people with disabilities to bring their service
30
animals onto business premises
more
frequent and rigorous cleaning
“service animal” is adapted from 28 CFR 36.104 adopted
or carrying and picking up things for persons with mobility
against individuals with disabilities. The ADA
in whatever areas customers are generally
Guam Food Code Annex 1 – Public Health Reasons
225
1
allowed. Some, but not all, service animals wear special collars or harnesses.
2
Some, but not all, are licensed or certified and have identification papers.
3
Decisions regarding a food employee or applicant with a disability who needs to
4
use a service animal should be made on a case-by-case basis. An employer
5
must comply with health and safety requirements, but is obligated to consider
6
whether there is a reasonable accommodation that can be made. Guidance is
7
available from the U.S. Department of Justice, Civil Rights Division, Disability
8
Rights Section or
9
Federal agency which has the lead in these matters, in documents such as,
10
“Commonly Asked Questions About Service Animals in Places of Business”;
11
“The Americans with Disabilities Act Questions and Answers”; “A Guide to
12
Disability Rights Laws”; and “Americans with Disabilities Act Title III Technical
13
Assistance Manual, 1994 Supplement.” The ADA Information Line is 800-514-
14
0301 (voice) or 800-514-0383 (TDD) and the Internet Home Page address is
15
http://www.usdoj.gov/crt/ada/adahom1.htm.
the U.S. Equal Employment Opportunity Commission, the
16
Chapter 7 Poisonous or Toxic Materials
17
7-101.11
Identifying Information, Prominence.*
18
Original
19
Containers
20
The accidental contamination of food or food-contact surfaces can cause
21
serious illness. Prominent and distinct labeling helps ensure that poisonous
22
and toxic materials including personal care items are properly used.
23
Working
24
Containers
25
It is common practice in food establishments to purchase many poisonous or
26
toxic materials including cleaners and sanitizers in bulk containers. Working
27
containers are frequently used to convey these materials to areas where they
28
will be used, resulting in working containers being stored in different locations
29
in the establishment. Identification of these containers with the common name
30
of the material helps prevent the dangerous misuse of the contents.
7-102.11
Common Name.*
Guam Food Code Annex 1 – Public Health Reasons
226
Storage
7-201.11
3
Separation
of
4
requirements of this section ensures that food, equipment, utensils, linens, and
5
single-service and
6
contamination.
7
above or adjacent to food could result in contamination of the food from
8
spillage.
9
Presence
10
and Use
11
The presence in the establishment of poisonous or toxic materials that are
12
not required
13
represents an unnecessary risk to both employees and consumers.
14
Preserving food safety depends in part on the appropriate and proper storage
15
and use of poisonous or toxic materials that are necessary to the maintenance
16
and operation of a food establishment.
17
pose a hazard if they are used in a manner that contradicts the intended use
18
of the material as described by the manufacturer on the material's label.
19
additional poisonous or toxic materials are present, there is an unwarranted
20
increased potential for contamination due to improper storage (e.g., overhead
21
spillage that could result in the contamination of food, food-contact surfaces, or
22
food equipment) or inappropriate application.
1
Separation.*
2
23
poisonous
and
single-use
toxic
materials in accordance with the
articles
are properly
protected
from
For example, the storage of these types of materials directly
7-202.11
for
the
Restriction.*
maintenance
7-202.12
and
operation of
the
establishment
Even those that are necessary can
If
Conditions of Use.*
24
Failure to properly use poisonous or toxic materials can be dangerous. Many
25
poisonous or toxic materials have general use directions on their label. Failure to
26
follow the stated instructions could result in injury to employees and consumers
27
through direct contact or the contamination of food.
28
Particular precautions must be taken during the application of poisonous or
29
toxic materials to prevent the contamination of food and other food-contact
Guam Food Code Annex 1 – Public Health Reasons
227
1
surfaces. Residues of certain materials are not discernible to the naked eye and
2
present an additional risk to the employee and consumer.
3
Because of the toxicity of restricted use pesticides, they can only be applied by
4
certified operators. A certified operator would be aware of the dangers involved
5
in the contamination of food and food-contact surfaces during the application of
6
these materials. Improperly applied pesticides present health risks to employees
7
as well as consumers and special precautions must be taken when restricted
8
use pesticides are applied.
9
Container
7-203.11
Poisonous or Toxic Material Containers.*
10
Prohibitions
11
Use of poisonous or toxic material containers to store, transport, or dispense
12
food is prohibited because of the potential for contamination of the food. The
13
risk of serious medical consequences to anyone consuming food stored in these
14
containers coupled with the lack of confidence that all of the material could or
15
would be removed in the wash and
16
prohibiting this practice.
17
Chemicals 7-204.11
18
See explanation in § 4-501.114.
19
Chemical sanitizers are included with poisonous or toxic materials because
20
they may be toxic if not used in accordance with requirements listed in the
21
Code of Federal Regulations (CFR).
22
excess of the CFR requirements can be harmful because residues of the
23
materials remain. The CFR reference that is provided lists concentrations of
24
sanitizers that are considered safe.
25
7-204.12
sanitizing procedures are reasons for
Sanitizers, Criteria.*
Large concentrations of sanitizer in
Chemicals for Washing Fruits and Vegetables,
Criteria.*
26
27
7-204.13
Boiler Water Additives, Criteria.*
28
7-204.14
Drying Agents, Criteria.*
29
If the chemical wash, boiler water additive, or drying agent used is not made
30
up
of
components
that are approved as food additives or generally
Guam Food Code Annex 1 – Public Health Reasons
228
1
recognized as safe, illness may result. This could be due to residues that may
2
remain from the use of compounds such as unrecognized drying agents. This
3
is why only those chemicals that are listed in the CFR can be used.
4
Chemicals that are not listed for these uses may be submitted for review by
5
filing a Food Additive Petition.
6
drying agents are classified as food additives because of the possibility that
7
they may end up in food. Therefore, they are subject to review before being
8
used or listed in the CFR.
9
21 CFR Section 173.315 specifically identifies chemicals that may be used in
Wash chemicals, boiler water additives, and
does not specify any maximum level
10
washing fruits and vegetables, but it
11
(2000 ppm or otherwise) of chemical usage for sodium hypochlorite.
12
acknowledges the use of sodium hypochlorite on fruits and vegetables and
13
also allows calcium hypochlorite to be used interchangeably with sodium
14
hypochlorite under 21 CFR 173.315.
15
Boiler water additives that may be safely used in the preparation of steam that
16
may contact food, and their condition of use, are identified in 21 CFR 173.310
17
Boiler Water Additives.
18
Lubricants 7-205.11
19
Lubricants used on food equipment may directly or indirectly end up in the food.
20
Therefore, the lubricants used must be approved as food additives or generally
21
recognized as safe and listed in the CFR. Lubricants that are not safe present
22
the possibility of foodborne illness if they find their way into the food.
23
Pesticides
24
FDA
Incidental Food Contact, Criteria.*
7-206.11
Restricted Use Pesticides, Criteria.*
7-206.12
Rodent Bait Stations.*
25
Open bait stations may result in the spillage of the poison being used.
26
Also, it is easier for pests to transport the potentially toxic bait throughout the
27
establishment. Consequently, the bait may end up on food-contact surfaces and
28
ultimately in the food being prepared or served.
29
7-206.13
Tracking Powders, Pest Control and Monitoring.*
Guam Food Code Annex 1 – Public Health Reasons
229
1
The use of tracking powder pesticides presents the potential for the powder to
2
be dispersed throughout the establishment.
3
directly or indirectly contaminate food being prepared.
4
could adversely affect both the safety and quality of the food and, therefore,
5
tracking powder pesticides are not allowed.
6
Medicines
7
Medicines that are not necessary for
8
unjustified risk to the health of other employees and consumers due to misuse
9
and/or improper storage.
7-207.11
Consequently, the powder could
This contamination
Restriction and Storage.*
the health of employees present an
10
There are circumstances that require employees or children in a day care center
11
to have personal medications on hand in the establishment.
12
misuse, personal medications must be labeled and stored in accordance with
13
the requirements stated for poisonous or toxic materials. Proper labeling and
14
storage of medicines to ensure that they are not accidentally misused or
15
otherwise contaminate food or food-contact surfaces.
7-207.12
16
To prevent
Refrigerated Medicines, Storage.*
17
Some employee medications may require refrigerated storage. If employee
18
medications are stored in a food refrigerator, precautions must be taken
19
to prevent the contamination of other items stored in the same refrigerator.
20
First Aid
21
Supplies
22
First aid supplies for employee use must be identified and stored in accordance
23
with the requirements of this
24
contamination of food, food equipment, and other food-contact surfaces.
25
Other Personal
26
Care Items
27
Employee personal care items may serve as a source of contamination and
28
May contaminate food, food equipment, and food-contact surfaces if they are
29
not properly labeled and stored.
30
Storage and
7-208.11
Storage.*
Code in order to preclude the accidental
7-209.11
7-301.11
Storage.
Separation.*
Guam Food Code Annex 1 – Public Health Reasons
230
1
Display
2
Poisonous or toxic materials held for sale on store shelves or stored in stock
3
rooms present a risk of contamination of food, equipment, utensils, linens, and
4
single-service and single-use articles if not stored properly.
5
Chapter 8 Compliance and Enforcement
6
7
Construction
8-201.12
Contents of the Plans and Specifications.
8
Inspection and
8-203.10
Preoperational Inspections.
9
Approval
10
In conjunction
with the
11
committee, FDA has participated in developing a document that is intended to
12
assist regulators in reviewing food establishment plans, and industry in
13
understanding what is expected in the plan review process. For several years,
14
this FDA/CFP Food Establishment Plan Review Guide – 2000 has been used in
15
the FDA State Training Team Plan Review courses. It can be accessed through
16
http://www.cfsan.fda.gov/~dms/prev-toc.html.
17
At the plan review stage, the regulatory authority may be dealing with an
18
agent of the permit applicant who is seeking a building permit and who is
19
not in a position to discuss plans for safely conducting the food operation.
20
Nonetheless, the plan review step
21
foundation
22
compliance with the Code over time. Standard operating procedures (SOPs)
23
are a part of that foundation and ideally are developed in tandem with
24
designing the facility. Consequently, as an integral part of the plan review
25
process, discussion needs to occur about such procedures and their scope.
26
SOPs need to be developed by the time of the preoperational inspection
27
and put into effect when the food operation begins. It is recommended that such
28
procedures
29
conveyed to
that
be
the
enables
written,
Conference
the
Food
presents
Protection
for reference
employees, and
Review
to proactively sustain
by the person in charge,
available for review by the
Guam Food Code Annex 1 – Public Health Reasons
231
Plan
a unique opportunity to lay a
proposed operation
available
appropriate
for
1
regulatory authority during inspections. Operating procedures should include
2
definitive practices and expectations that ensure that:
3
(1)
The
transmission
of
foodborne
disease is
prevented by
4
managing job applicants and food employees as specified under
5
Subpart 2-201,
6
(2)
7
8
Food is received from approved sources as specified under
§ 3-201.11,
(3)
Food is managed so that the safety and integrity of the food from
9
the time of delivery to the establishment throughout its storage,
10
preparation, and transportation to the point of sale or service to the
11
consumer is protected,
12
(4)
Potentially hazardous (time/temperature control for safety) food is
13
maintained, including freezing, cold holding, cooking, hot holding,
14
cooling,
15
temperature and time requirements specified under Parts 3-4 and
16
3-5,
17
(5)
reheating,
and serving
in
conformance with the
Warewashing is effective, including assurance that the chemical
18
solutions and exposure times necessary for cleaning and sanitizing
19
utensils and food-contact surfaces of equipment are provided as
20
specified under Parts 4-6 and 4-7, and
21
22
(6)
Records that are specified
under §§ 3-203.11, 3-203.12, and
5-205.13 are retained for inspection.
23
During the plan review stage, the regulatory authority and a management
24
representative of the proposed food establishment should discuss available
25
training options that may be used to train food employees and the person in
26
charge regarding food safety as it relates to their assigned duties. By the time of
27
the preoperational inspection, operating procedures for training should include
28
definitive practices and expectations of how the management of the proposed
29
food establishment plans to comply with & 2-103.11(L) of this Code which
Guam Food Code Annex 1 – Public Health Reasons
232
1
requires the person in charge to assure that food employees are properly trained
2
in food safety as it relates to their assigned duties.
8-402.10
3
Competency of Inspectors.
4
Regulatory agencies are encouraged to use Standard #2 of the draft FDA’s
5
Recommended
6
(http://www.cfsan.fda.gov/~dms/ret-toc.html) to ensure employees who inspect
7
food establishments are properly trained.
8
encouraged to seek food safety certification through a nationally recognized
9
and accredited program.
National
Retail
Food
Regulatory
Standards
Regulatory inspectors are also
Guam Food Code Annex 1 – Public Health Reasons
233
Program
1
Guam Annex
2
2
Management of Food Safety
Practices – Achieving Active
3
4
Managerial Control of Foodborne
5
Illness Risk Factors
6
1.
ACTIVE MANAGERIAL CONTROL
7
2.
INTRODUCTION TO HACCP
8
3.
THE HACCP PRINCIPLES
9
4.
THE PROCESS APPROACH – A PRACTICAL APPLICATION OF HACCP AT
RETAIL TO ACHIEVE ACTIVE MANAGERIAL CONTROL
10
11
5.
FDA RETAIL HACCP MANUALS
12
6.
ADVANTAGES OF THE HACCP PRINCIPLES
13
7.
SUMMARY
14
8.
ACKNOWLEDGEMENTS
15
9.
RESOURCES AND REFERENCES
17
1.
ACTIVE MANAGERIAL CONTROL
18
(A)
What is the common goal of operators and regulators of retail food
16
19
and food service establishments and what is presently being done to
20
achieve this goal?
21
The
common
goal
of operators and regulators of retail and
food service
22
establishments is to produce safe, quality food for consumers.
23
of regulatory oversight of retail and food service operations, regulatory inspections
24
have emphasized the recognition and correction of food safety violations that exist
25
at the time of the inspection. Recurring violations have traditionally been handled
26
through re-inspections or enforcement activities such as fines, suspension of
27
permits, or closures. Operators of retail and food service establishments routinely
Since the onset
Guam Food Code Annex 2 – Management of Food Safety Practices – Achieving Active
Managerial Control of Foodborne Illness Risk Factors
1
1
respond to inspection findings by correcting violations, but often do not implement
2
proactive systems of control to prevent violations from recurring.
3
inspection and enforcement system has done a great deal to improve basic sanitation
4
and to upgrade facilities in the United States, it emphasizes reactive rather than
5
preventive measures to food safety. Additional measures must be taken on the part of
6
operators and regulators to better prevent or reduce foodborne illness. Annex 3 of
7
the Guam Food Code provides additional information on conducting risk-based
8
inspections. It should be reviewed in conjunction with the material found in this
9
Annex to better understand the role of the regulator in facilitating active
While this type of
10
managerial control by the operator.
11
(B)
12
The responsibility of providing safe food to the consumer is shared by many people in
13
every stage in the production of food, including consumers, themselves. Since most
14
consumers
15
significant share of the responsibility for providing safe food to the consumer rests
16
with these facilities. Working together with their regulatory authorities, operators of
17
retail and food service establishments can make the greatest impact on food safety.
18
(C)
19
The Centers for Disease Control and Prevention (CDC) Surveillance Report for
20
1993-1997, “Surveillance
21
identifies the most significant contributing factors to foodborne illness. Five of these
22
broad categories of contributing factors directly relate to food safety concerns within
23
retail and food service establishments and are collectively termed by the FDA as
24
“foodborne illness risk factors.” These five broad categories are:
Who has the ultimate responsibility for providing safe food to the consumer?
receive their food from retail and food service establishments, a
How can foodborne illness be reduced?
for
Foodborne - Disease Outbreaks – United States,”
25
Food from Unsafe Sources
26
Inadequate Cooking
27
Improper Holding Temperatures
28
Contaminated Equipment
29
Poor Personal Hygiene.
30
In 1998, FDA initiated a project designed to determine the incidence of foodborne
Guam Food Code Annex 2 – Management of Food Safety Practices – Achieving Active
Managerial Control of Foodborne Illness Risk Factors
2
1
illness risk factors in retail and food service establishments. Inspections focusing on
2
the occurrence of foodborne illness risk factors were conducted in establishments
3
throughout the United States. The results of this project are published in the 2000
4
Report of the
5
Factors, commonly referred to as the “FDA Baseline Report.” The Baseline Report
6
is
7
http://www.cfsan.fda.gov/~dms/retrsk.html. The data collection project was repeated in
8
2003 and the results are published in the FDA Report on the Occurrence of Foodborne
9
Illness Risk Factors in Selected Institutional Foodservice, Restaurant, and Retail Food
10
Store Facility Types (2004). This second report is available from FDA through the
11
following website: http://www.cfsan.fda.gov/~dms/retrsk2.html . An additional data
12
collection project is planned for 2008.
13
The CDC Surveillance Report and the results from the FDA Baseline Report and
14
second data collection project, support the concept that operators of retail and food
15
service establishments must be proactive and implement food safety management
16
systems that will prevent, eliminate, or reduce the occurrence of foodborne illness
17
risk factors. By reducing the occurrence of foodborne illness risk factors, foodborne
18
illness can also be reduced.
19
(D)
20
To effectively reduce the occurrence of foodborne illness risk factors, operators of
21
retail and food service establishments must focus their efforts on achieving active
22
managerial control. The term “active managerial control” is used to describe
23
industry’s responsibility for developing and implementing food safety management
24
systems to prevent, eliminate, or reduce the occurrence of foodborne illness risk
25
factors.
26
Active managerial control means the purposeful incorporation of specific actions or
27
procedures by industry management into the operation of their business to attain
28
control over foodborne illness risk factors. It embodies a preventive rather than
29
reactive approach to food safety through a continuous system of monitoring and
30
verification.
31
There are many tools that can be used by industry to provide active managerial
FDA Retail Food Program Database of Foodborne Illness Risk
available
from
FDA
through
the
following
website:
How can the occurrence of foodborne illness risk factors be reduced?
Guam Food Code Annex 2 – Management of Food Safety Practices – Achieving Active
Managerial Control of Foodborne Illness Risk Factors
3
1
control of foodborne illness risk factors. Regulatory inspections and follow-up activities
2
must also be proactive by using an inspection process designed to assess the
3
degree of active managerial control that retail and food service operators have over
4
the foodborne illness risk factors. In addition, regulators must assist
5
in
6
industry systems to prevent the occurrence of foodborne illness risk factors.
7
Elements of an effective food safety management system may include the
8
following:
developing
and
operators
implementing voluntary strategies to strengthen existing
9
Certified food protection managers who have shown a proficiency in
10
required information by passing a test that is part of an accredited
11
program
12
Standard
13
operational steps in a food preparation process, such as cooling
14
Recipe cards that contain the specific steps for preparing a food item
15
and the food safety critical limits, such as final cooking temperatures,
16
that need to be monitored and verified
17
Purchase specifications
18
Equipment and facility design and maintenance
19
Monitoring procedures
20
Record keeping
21
Employee health policy for restricting or excluding ill employees
22
Manager and employee training
23
On-going quality control and assurance
24
Specific goal-oriented plans, like Risk Control Plans (RCPs), that outline
25
procedures for controlling foodborne illness risk factors.
operating
procedures
(SOPs)
for
performing critical
26
A food safety management system based on Hazard Analysis and Critical Control
27
Point (HACCP) principles contains many of these elements and provides a
28
comprehensive
29
occurrence of foodborne illness risk factors.
framework by
which
an
operator can effectively control the
Guam Food Code Annex 2 – Management of Food Safety Practices – Achieving Active
Managerial Control of Foodborne Illness Risk Factors
4
1
2.
INTRODUCTION TO HACCP
2
(A)
What is HACCP and how can it be used by operators and regulators of retail
3
food and food service establishments?
4
Hazard Analysis and Critical Control Point (HACCP) is a systematic approach to
5
identifying, evaluating, and controlling food safety hazards. Food safety hazards are
6
biological, chemical, or physical agents that are reasonably likely to cause illness or
7
injury in the absence of their control.
8
ensure that hazards are prevented, eliminated, or reduced to an acceptable level
9
before a food reaches the consumer, it embodies the preventive nature of “active
Because a HACCP program is designed to
10
managerial control.”
11
Active managerial control through the use of HACCP principles is achieved by
12
identifying the food safety hazards attributed to products, determining the necessary
13
steps that will control the identified hazards, and implementing on-going practices or
14
procedures that will ensure safe food.
15
Like many other quality assurance programs, HACCP provides a common-sense
16
approach to identifying and controlling problems that are likely to exist in an
17
operation.
18
already incorporate some, if not all, of the principles of HACCP.
19
good basic sanitation, a solid employee training program, and other prerequisite
20
programs, a food safety management system based on HACCP principles will
21
prevent, eliminate, or reduce the occurrence of foodborne illness risk factors that
22
lead to out-of-control hazards.
23
HACCP represents an important tool in food protection that small independent
24
businesses as well as national companies can use to achieve active managerial
25
control of risk factors. The Food Code requires a comprehensive HACCP plan
26
when conducting certain specialized processes at retail such as when a variance
27
is granted or when a reduced oxygen packaging method is used. However, in
28
general, the implementation of HACCP at the retail level is voluntary. FDA
29
endorses the voluntary implementation of food safety management systems based on
30
HACCP principles as an effective means for controlling the occurrence of foodborne
31
illness risk factors that result in out-of-control hazards.
Consequently, many food safety management systems at the retail level
Combined with
Guam Food Code Annex 2 – Management of Food Safety Practices – Achieving Active
Managerial Control of Foodborne Illness Risk Factors
5
1
While the operator is responsible for developing and implementing a system of
2
controls to prevent foodborne illness risk factors, the role of the regulator is to
3
assess whether the system the operator has in place is achieving control of
4
foodborne illness risk factors.
5
enhance
6
approach.
7
effectiveness of food safety management systems implemented by industry to control
8
foodborne illness risk factors.
9
The
the
effectiveness of routine inspections by incorporating a risk-based
This
principles
Using HACCP principles during inspections will
helps
of
inspectors focus
HACCP
are
also
their inspection
an
integral
part
on
evaluating
the
of the draft FDA’s
10
Recommended Voluntary National Retail Food Regulatory Program Standards. For
11
regulatory program managers, the use of risk-based inspection methodology based
12
on HACCP principles is a viable and practical option for evaluating the degree of
13
active managerial control operators have over the foodborne illness risk factors. The
14
complete set of Program Standards is available from FDA through the following
15
website: http://www.cfsan.fda.gov/~dms/ret-toc.html.
16
(B)
17
In November 1992, the National Advisory Committee on Microbiological Criteria for
18
Foods (NACMCF) defined seven widely accepted HACCP principles that explained the
19
HACCP process in great detail. In 1997, NACMCF reconvened to review the 1992
20
document and compare it to current HACCP guidance prepared by the CODEX
21
Committee on Food Hygiene.
22
HACCP and defined HACCP
23
evaluation, and control of food safety. Based on a solid foundation of prerequisite
24
programs to control basic operational and sanitation conditions, the
25
seven basic principles are used to accomplish this objective:
What are the Seven HACCP Principles?
as
Based on this review, NACMCF again endorsed
a
systematic
approach
26
Principle 1: Conduct a hazard analysis
27
Principle 2: Determine the critical control points (CCPs)
28
Principle 3: Establish critical limits
29
Principle 4: Establish monitoring procedures
30
Principle 5: Establish corrective actions
31
Principle 6: Establish verification procedures
to the identification,
Guam Food Code Annex 2 – Management of Food Safety Practices – Achieving Active
Managerial Control of Foodborne Illness Risk Factors
6
following
1
Principle 7: Establish record-keeping and documentation procedures.
2
This Annex will provide a brief overview of each of the seven principles of
3
HACCP. A more comprehensive discussion of these principles is available from
4
FDA
5
http://www.cfsan.fda.gov/~comm/nacmcfp.html.
6
scheme for applying and implementing the HACCP principles in retail and food
7
service establishments is presented.
8
(C)
9
In order for a HACCP system to be effective, a strong foundation of procedures that
10
address the basic operational and sanitation conditions within an operation must first
11
be developed and implemented. These procedures are collectively termed “prerequisite
12
programs.” When prerequisite programs are in place, more attention can be given to
13
controlling hazards associated with the food and its preparation. Prerequisite programs
14
may include such things as:
by accessing the NACMCF guidance document on the FDA website at:
Following the overview, a practical
What are Prerequisite Programs?
15
Vendor certification programs
16
Training programs
17
Allergen management
18
Buyer specifications
19
Recipe/process instructions
20
First-In-First-Out (FIFO) procedures
21
Other Standard Operating Procedures (SOPs).
22
Basic prerequisite programs should be in place to:
23
Protect products from contamination by biological, chemical, and physical
24
food safety hazards
25
Control bacterial growth that can result from temperature abuse
26
Maintain equipment.
27
Additional information about prerequisite programs and the types of activities
28
usually included in them can be found in the FDA’s Retail HACCP manuals
29
discussed later in this Annex or by accessing the NACMCF guidance document on
30
the FDA website.
Guam Food Code Annex 2 – Management of Food Safety Practices – Achieving Active
Managerial Control of Foodborne Illness Risk Factors
7
1
3.
THE HACCP PRINCIPLES
2
(A)
Principle #1: Conduct a Hazard Analysis
3
(1)
What is a food safety hazard?
4
A hazard is a biological, chemical, or physical property that may cause a food to
5
be unsafe for human consumption.
6
(2)
7
Biological hazards include bacterial, viral, and parasitic microorganisms. See Table
8
1 in this Annex for a listing of selected biological hazards. Bacterial pathogens
9
comprise the majority of confirmed foodborne disease outbreaks and cases.
10
Although cooking destroys the vegetative cells of foodborne bacteria to acceptable
11
levels,
12
botulinum, and Clostridium perfringens survive cooking and may germinate and
13
grow if food is not properly cooled or held after cooking. The toxins produced by
14
the vegetative cells of Bacillus cereus, Clostridium botulinum, and Staphylococcus
15
aureus
16
recontamination with vegetative cells of bacteria such as
17
Campylobacter jejuni is also a major concern for operators of retail and food
18
service establishments.
19
Viruses such as norovirus, hepatitis
20
contamination from human feces. Recent outbreaks have also shown that these
21
viruses may be transmitted via droplets in the air. In limited cases, foodborne
22
viruses may occur in
23
shellfish
24
contamination
25
employees or unclean equipment and utensils. Unlike bacteria, a virus cannot
26
multiply outside of a living cell.
27
ineffective because many foodborne viruses seem to exhibit heat resistance
28
exceeding
29
Obtaining food
30
ready-to-eat food as well as proper handwashing, and implementing an employee
What are biological hazards?
spores
may
of
spore-forming
not
be
bacteria
destroyed
to
such as Bacillus cereus, Clostridium
safe
A,
levels
and
by
reheating.
Post-cook
Salmonellae and
rotavirus are directly related to
raw commodities contaminated by human feces (e.g.,
harvested from unapproved, polluted waters).
In most cases, however,
of food by viruses is the result of cross-contamination by ill food
cooking
temperature
Cooking as a control for viruses may be
requirements,
under
laboratory
conditions.
from approved sources, practicing no bare hand contact with
Guam Food Code Annex 2 – Management of Food Safety Practices – Achieving Active
Managerial Control of Foodborne Illness Risk Factors
8
1
health policy to restrict or exclude ill employees are important control measures for
2
viruses.
3
Parasites are most often animal host-specific, but can include humans in their life
4
cycles.
5
products or cross-contamination of ready-to-eat food with raw animal foods,
6
untreated water, or contaminated equipment or utensils.
7
do not grow in food, so control is focused on destroying the parasites and/or
8
preventing their introduction. Adequate cooking destroys parasites. In addition,
9
parasites in fish to be consumed raw or undercooked can also be destroyed by
10
effective freezing techniques. Parasitic contamination by ill employees can be
11
prevented by proper handwashing, no bare hand contact with ready-to-eat food,
12
and implementation of an employee health policy to restrict or exclude ill
13
employees. Annex 2, Table 1.
14
and Control Measures
Parasitic infections are
commonly associated with undercooking meat
Like viruses, parasites
Selected Biological Hazards Found at Retail, Associated Foods,
15
Guam Food Code Annex 2 – Management of Food Safety Practices – Achieving Active
Managerial Control of Foodborne Illness Risk Factors
9
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
HAZARD
ASSOCIATED FOODS
CONTROL MEASURES
Bacillus cereus
Meat, poultry, starchy foods (rice, potatoes),
Cooking, cooling, cold holding, hot holding
(intoxication caused by heat stable,
puddings, soups, cooked vegetables
Bacteria
preformed emetic toxin
and infection by heat labile, diarrheal
toxin)
Campylobacter jejuni
Poultry, raw milk
Cooking, handwashing, prevention of cross-
contamination
Clostridium botulinum
Vacuum-packed foods, reduced oxygen
Thermal processing (time + pressure),
packaged foods, under-processed canned
cooling, cold holding, hot holding, acidification
foods, garlic-in-oil mixtures, time/temperature
and drying, etc.
abused baked potatoes/sautéed onions
Clostridium perfringens
Cooked meat and poultry, Cooked meat and
Cooling, cold holding, reheating, hot holding
poultry products including casseroles, gravies
E. coli O157:H7 (other shiga toxin-
Raw ground beef, raw seed sprouts, raw milk,
Cooking, no bare hand contact with RTE
producing E. coli)
unpasteurized juice, foods contaminated by
foods, employee health policy, handwashing,
infected food workers via fecal-oral route
prevention of cross-contamination,
pasteurization or treatment of juice
Listeria monocytogenes
Salmonella spp.
Raw meat and poultry, fresh soft cheese,
Cooking, date marking, cold holding,
paté, smoked seafood, deli meats, deli
handwashing, prevention of cross-
salads
contamination
Meat and poultry, seafood, eggs, raw seed
Cooking, use of pasteurized eggs, employee
sprouts, raw vegetables, raw milk,
health policy, no bare hand contact with RTE
unpasteurized juice
foods, handwashing, pasteurization or
treatment of juice
Shigella spp.
Raw vegetables and herbs, other foods
Cooking, no bare hand contact with RTE
contaminated by infected workers via fecal-
foods, employee health policy, handwashing
oral route
Staphylococcus aureus
RTE PHF foods touched by bare hands after
Cooling, cold holding, hot holding, no bare
(preformed heat stable toxin)
cooking and further time/temperature abused
hand contact with RTE food, handwashing
Vibrio spp.
Seafood, shellfish
Cooking, approved source, prevention of
cross-contamination, cold holding
34
35
36
Anisakis simplex
37
Taenia spp.
Beef and pork
Cooking
38
Trichinella spiralis
Pork, bear, and seal meat
Cooking
39
Parasites
Various fish (cod, haddock, fluke, pacific
Cooking, freezing
salmon, herring, flounder, monkfish)
Viruses
Guam Food Code Annex 2 – Management of Food Safety Practices – Achieving Active
Managerial Control of Foodborne Illness Risk Factors
10
1
2
3
4
5
6
7
8
9
10
11
12
Hepatitis A and E
Shellfish, any food contaminated by infected
Approved source, no bare hand contact with
worker via fecal-oral route
with RTE food, minimizing bare hand contact
with foods not RTE, employee health policy,
handwashing
Other Viruses (Rotavirus,
Any food contaminated by infected worker
No bare hand contact with RTE food,
Norovirus, Reovirus)
via fecal-oral route
minimizing bare hand contact with foods not
RTE, employee health policy, handwashing
RTE = ready-to-eat
PHF = potentially hazardous food (time/temperature control for safety food)
13
14
15
(3)
What are Chemical Hazards?
16
Chemical hazards may be naturally occurring or may be added during the
17
processing of food. High levels of toxic chemicals may cause acute cases of
18
foodborne illness, while chronic illness may result from low levels.
19
The Code of Federal Regulations (http://www.access.gpo.gov/nara/cfr/cfr-table-
20
search.html), Title 21 Food and Drugs, provides guidance on naturally occurring
21
poisonous or deleterious substances,
22
Contaminants in Food for Human Consumption and Food Packaging Material, and
23
184 Direct Food Substances Affirmed as Generally Recognized as Safe.
24
CFR also provide allowable limits for many of the chemicals added during
25
processing, e.g., 21 CFR Part 172 Food Additives Permitted for Direct Addition to
26
Food For Human Consumption.
27
FDA’s Compliance Policy Guidelines also provide information on naturally occurring
28
chemicals (http://www.fda.gov/ora/compliance_ref/cpg/default.htm). See Chapter 5 –
29
Foods, Colors and Cosmetics. Examples include sections:
e.g.,
21 CFR Parts 109 Unavoidable
The
30
540.600 Fish, Shellfish, Crustaceans, and Other Aquatic Animals – Fresh,
31
Frozen or Processed – Methyl Mercury,
32
555.400 Foods – Adulteration with Aflatoxin, and
Guam Food Code Annex 2 – Management of Food Safety Practices – Achieving Active
Managerial Control of Foodborne Illness Risk Factors
11
1
570.200 Aflatoxin in Brazil Nuts, .375 Peanuts and Peanut Products,
2
and 500 Pistachio Nuts.
3
Table 2 of this Annex provides additional examples of chemical hazards, both
4
naturally occurring and added.
5
6
7
(4)
Food Allergens As Food Safety Hazards
8
Recent studies indicate that over 11 million Americans suffer from one or more
9
food allergies. A food allergy is caused by a naturally-occurring protein in a food
10
or a food ingredient, which is referred to as an “allergen.” For unknown reasons,
11
certain individuals produce immunoglobulin E (IgE) antibodies specifically directed to
12
food allergens. When these sensitive individuals ingest sufficient concentrations of
13
foods containing these allergens, the
14
antibodies and elicit an abnormal immune response. A food allergic response is
15
commonly characterized by hives or other itchy rashes, nausea, abdominal pain,
16
vomiting and/or diarrhea, wheezing, shortness of breath, and swelling of various
17
parts of the body. In severe cases, anaphylactic shock and death may result.
18
Many foods, with or without identifiable allergens, have been reported to cause food
19
allergies. However, FDA believes there is scientific consensus that the following
20
foods can cause a serious allergic reaction in sensitive individuals; these foods
21
account for 90% or more of all food allergies:
allergenic proteins interact with IgE
22
Milk
23
Egg
24
Fish (such as bass, flounder, or cod)
25
Crustacean shellfish (such as crab, lobster, or shrimp)
26
Tree nuts (such as almonds, pecans, or walnuts)
27
Wheat
28
Peanuts
29
Soybeans.
Guam Food Code Annex 2 – Management of Food Safety Practices – Achieving Active
Managerial Control of Foodborne Illness Risk Factors
12
1
Consumers with food allergies rely heavily on information contained on food labels
2
to avoid food allergens. Each year, FDA receives reports from consumers who
3
have
4
Frequently, these reactions occur either because product labeling does not inform
5
the consumer of the presence of the allergenic ingredient in the food or because
6
of the cross-contact of a food with an allergenic substance not intended as an
7
ingredient of the food during processing and preparation.
8
In August 2004, the Food Allergen Labeling and Consumer Protection Act (Public
9
Law 108-282, Title II) was enacted, which defines the term “major food allergen.”
experienced an adverse reaction following exposure to a food allergen.
10
The definition of
11
paragraph 1-201.10(B)) is consistent with the definition in the new law. The
12
following requirements are included in the new law:
“major food allergen” adopted for use in the Food Code
(see
13
For foods labeled on or after January 1, 2006, food manufacturers must
14
identify in plain language on the label of the food any major food
15
allergen used as an ingredient in the food, including a coloring,
16
flavoring, or incidental additive.
17
FDA is to conduct inspections to ensure that food facilities comply with
18
practices to reduce or eliminate cross-contact of a food with any major
19
food allergens that are not intentional ingredients of the food.
20
Within 18 months of the date of enactment of the new law (i.e., by
21
February 2, 2006), FDA must submit a report to Congress that
22
analyzes the results of its food inspection findings and addresses a
23
number of specific issues related to the production, labeling, and
24
recall of foods that contain an undeclared major food allergen.
25
Within 2 years of the date of enactment of the new law (i.e., by
26
August 2, 2006), FDA must issue a proposed rule, and
27
years of the date of enactment of the new law (i.e., by August 2,
28
2008), FDA must issue a final rule to define and permit the use
29
of the term “gluten-free” on food labeling.
Guam Food Code Annex 2 – Management of Food Safety Practices – Achieving Active
Managerial Control of Foodborne Illness Risk Factors
13
within 4
1
FDA is to work in cooperation with the Conference for Food Protection
2
(CFP) to pursue revision of the Food Code to provide guidelines for
3
preparing allergen-free foods in food establishments.
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
Annex 2, Table 2. Common Chemical Hazards at Retail, Along with Their
21
Associated Foods and Control Measures
22
23
Chemical Hazards
24
25
26
27
28
29
30
Naturally Occurring:
Scombrotoxin
Associated Foods
Control measures
Primarily associated with tuna
Check temperatures at receiving;
fish, mahi-mahi, blue fish,
store at proper cold holding
anchovies bonito, mackerel;
temperatures; buyer specifications:
Also found in cheese
obtain verification from supplier that
product has not been temperature
abused prior to arrival in facility.
Guam Food Code Annex 2 – Management of Food Safety Practices – Achieving Active
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1
2
3
4
5
6
7
Ciguatoxin
8
Tetrodoxin
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
Mycotoxins
24
25
26
Toxic mushroom species
27
28
29
30
31
32
33
34
35
36
37
Shellfish toxins
Reef fin fish from extreme SE
Ensure fin fish have not
US, Hawaii, and tropical areas;
been caught:
barracuda, jacks, king
•
mackerel, large groupers, and
snappers
Purchase fish from approved
sources.
•
Fish should not be harvested
from an area that is subject to
an adverse advisory.
Puffer fish (Fugu; Blowfish)
Do not consume these fish.
Aflatoxin
Corn and corn products,
peanuts and peanut products,
use moldy or decomposed food.
Check condition at
receiving; do not
cottonseed, milk, and tree nuts
such as Brazil nuts, pecans,
pistachio nuts, and walnuts.
Other grains and nuts are
susceptible but less prone to
contamination.
Patulin
Apple juice products
Buyer Specification: obtain
verification from supplier or avoid
the use of rotten apples in
in juice manufacturing.
Numerous varieties of wild
Do not eat unknown varieties or
mushrooms
mushrooms from unapproved
source.
Molluscan shellfish from NE
Ensure molluscan shellfish are:
Paralytic shellfish
and NW coastal regions;
poisoning (PSP)
mackerel, viscera of lobsters
• from an approved source; and.
and Dungeness, tanner, and
• properly tagged and labeled.
red rock crabs
Diarrhetic shellfish
Molluscan shellfish in Japan,
poisoning (DSP)
western Europe, Chile, NZ,
eastern Canada
Neurotoxin shellfish
Molluscan shellfish from Gulf of
Guam Food Code Annex 2 – Management of Food Safety Practices – Achieving Active
Managerial Control of Foodborne Illness Risk Factors
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1
2
3
4
5
6
poisoning (NSP)
Mexico
Amnesic shellfish
Molluscan shellfish from NE
poisoning (ASP)
and NW coasts of NA; viscera
of Dungeness, tanner, red rock
crabs and anchovies.
7
Annex 2, Table 2. Common Chemical Hazards at Retail, Along with Their
8
Associated Foods and Control Measures
9
10
Chemical Hazards
Associated Foods
11
12
13
14
15
16
Naturally Occurring:
17
18
19
20
21
Phtyohaemmagglutinin
22
23
24
25
26
Added Chemicals:
27
PCBs
Fish
Comply with fish advisories.
28
29
30
31
32
33
Prohibited substances
Numerous substances are
Do not use chemical substances
34
35
Toxic elements/compounds
Fish exposed to organic
Pregnant women/women of
Mercury
mercury: shark, tilefish, king
childbearing age/nursing mothers,
Pyrrolizidine alkaloids
Control measures
Plants food containing these
Do not consume of food or
alkaloids. Most commonly
medicinals contaminated with these
found in members of the
alkaloids.
Borginaceae, Compositae, and
Leguminosae families.
Raw red kidney beans
Soak in water for at least 5 hours.
(Undercooked beans may be
Pour away the water.
more toxic than raw beans)
Boil briskly in fresh water, with
occasional stirring, for at least 10
minutes.
Environmental contaminants:
Any food may become
Follow label instructions for use of
Pesticides, fungicides,
contaminated.
environmental chemicals. Soil or
fertilizers, insecticides,
water analysis may be used to verify
antibiotics, growth hormones
safety.
(21 CFR 189)
prohibited from use in human
food; no substance may be
are not approved for use in human
food.
used in human food unless it
meets all applicable
requirements of the FD&C Act.
Guam Food Code Annex 2 – Management of Food Safety Practices – Achieving Active
Managerial Control of Foodborne Illness Risk Factors
16
1
2
3
4
5
6
7
mackerel and swordfish
and young children should not eat
Grains treated with mercury
shark, swordfish, king mackerel or
based fungicides
tilefish because they contain high
levels of mercury
Do not use mercury containing
fungicides on grains or animals.
8
9
10
11
Copper
12
Lead
High acid foods and beverages
Do not use vessels containing lead.
13
14
15
16
17
18
19
Preservatives and Food
Fresh fruits and Vegetables
Sulfiting agents added to a product
Additives:
Shrimp
in a processing plant must be
Sulfiting agents (sulfur
Lobster
declared on labeling.
dioxide, sodium and
Wine
High acid foods and beverages
Do not store high acid foods in
copper utensils; use backflow
prevention device on beverage
vending machines.
potassium bisulfite,
Do not use on raw produce in food
sodium and potassium
establishments.
metabisulfite)
20
21
22
23
24
Annex 2, Table 2. Common Chemical Hazards at Retail, Along with Their
25
Associated Foods and Control Measures
26
27
Chemical Hazards
Associated Foods
Control measures
28
29
30
31
32
33
34
35
Added Chemicals:
Nitrites/nitrates
Cured meats, fish, any food
Do not use more than the
Niacin
exposed to accidental
prescribed amount of curing
contamination, spinach
compound according to labeling
(niacin) is not currently approved
Meat and other foods to which
for use in meat or poultry with or
sodium nicotinate is added
poultry with or without nitrates or
nitrates.
Guam Food Code Annex 2 – Management of Food Safety Practices – Achieving Active
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1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
Flavor enhancers
Asian or Latin American food
Avoid using excessive amounts
Chemicals used in retail
Any food could become
Address through SOPs for proper
establishments (e.g. lubricants,
contaminated
labeling, storage, handling, and
Monosodium glutamate(MSG)
cleaners, sanitizers, cleaning
use of chemicals; retain Material
compounds, and paints
Safety Data Sheets for all chemicals.
Allergens
Foods containing or contacted
Use a rigorous sanitation regime
by:
to prevent cross contact between
Milk
allergenic and non-allergenic
Egg
ingredients.
Fish
Crustacean shellfish
Tree nuts
Wheat
Peanuts
Soybeans
19
(5)
What are Physical Hazards?
20
Illness and injury can result from foreign objects in food. These physical hazards
21
can result from contamination or poor procedures at many points in the food
22
chain from harvest to consumer, including those within the food establishment.
23
As establishments develop their food safety management systems, Annex 2,
24
Table 3 can be used to aid in the identification of sources of potential physical
25
hazards to the food
26
provides some examples of common physical hazards.
being prepared, served, or
sold.
Annex 2, Table 3
27
28
29
30
31
32
33
Annex 2, Table 3. Main Materials of Concern as Physical Hazards and Common Sources
34
35
Wood
Material
Glass fixtures
a, b
Injury Potential
Sources
Cuts, bleeding; may require surgery to
Bottles, jars, lights, utensils, gauge
find or remove
covers
Cuts, infection, choking; may require
Fields, pallets, boxes, buildings
surgery to remove
Guam Food Code Annex 2 – Management of Food Safety Practices – Achieving Active
Managerial Control of Foodborne Illness Risk Factors
18
1
2
3
Stones, metal
Choking, broken teeth
Fields, buildings, machinery, wire,
fragments
Cuts, infection; may require surgery to
employees
4
Insulation
Choking; long-term if asbestos
Building materials
5
Bone
Choking, trauma
Fields, improper plant processing
6
7
Plastic
Choking, cuts, infection; may require
Fields, plant packaging materials,
surgery to remove
pallets, employees
8
9
Personal effects
Choking, cuts, broken teeth; may
Employees
remove
require surgery to remove
10
a
Adapted from Corlett (1991).
11
12
b
Used with permission, “HACCP Principles and Applications”, Pierson and Corlett, Eds. 1992. Chapman & Hall,
New York, NY.
13
14
(6)
What is the purpose of the hazard analysis principle?
15
The purpose of hazard analysis is to develop a list of food safety hazards that are
16
reasonably likely to cause illness or injury if not effectively controlled.
17
(7)
18
The process of conducting a hazard analysis involves two stages:
19
1.
Hazard Identification
20
2.
Hazard Evaluation
21
Hazard identification can be thought of as a brain storming session. This stage
22
focuses on identifying the food safety hazards that might be present in the food
23
given the food preparation process used, the handling of the food, the facility,
24
and general characteristics of the food itself. During this stage, a review is made
25
of the ingredients used in the product, the activities conducted at each step in
26
the process, the equipment used, the final product, and its method of storage
27
and distribution, as well as the intended use and consumers of the product.
28
Based on this review, a list of potential biological, chemical, or physical hazards
29
is made at each stage in the food preparation process.
30
In stage two, the hazard evaluation, each potential hazard is evaluated based on
31
the severity of the potential hazard and its likely occurrence. The purpose of this
32
stage is to determine which of the potential hazards listed in stage one of the
How is the hazard analysis conducted?
Guam Food Code Annex 2 – Management of Food Safety Practices – Achieving Active
Managerial Control of Foodborne Illness Risk Factors
19
1
hazard analysis warrant control in the HACCP plan. Severity is the seriousness
2
of
3
determining the severity of a hazard include understanding the impact of the
4
medical condition caused by the illness, as well as the magnitude and duration of
5
the illness or injury. Consideration of the likely occurrence is usually based upon
6
a combination of experience, epidemiological data, and information in the technical
7
literature. Hazards that are not reasonably likely to occur are not considered in a
8
HACCP plan. During the evaluation of each potential hazard, the food, its method
9
of preparation, transportation, storage, and persons likely to consume the product
10
should be considered to determine how each of these factors may influence the
11
likely occurrence and severity of the hazard being controlled.
12
Upon completion of the hazard analysis, a list of significant hazards that must be
13
considered in the HACCP plan is made, along with any measure(s) that can be
14
used to control the hazards.
15
actions or activities that can be used to prevent, eliminate, or reduce a hazard.
16
Some control measures are not essential to food safety, while
17
Control measures essential to food safety like proper cooking, cooling, and
18
refrigeration of ready-to-eat, potentially hazardous foods (time/temperature control
19
for safety foods) are usually applied at critical control points (CCPs) in the HACCP
20
plan (discussed later). The term control measure is used because not all hazards
21
can be prevented, but virtually all can be controlled.
22
measure may be required for a specific hazard. Likewise, more than one hazard
23
may be addressed by a specific control measure (e.g., proper cooking).
24
(B)
Principle #2: Determine Critical Control Points (CCPs)
25
(1)
What is the Critical Control Point (CCP)?
26
A critical control point (CCP) means a point or procedure in a specific food system
27
where loss of control may result in an unacceptable health risk. Control can be
28
applied at this point and is essential to prevent or eliminate a food safety hazard
29
or reduce it to an acceptable level. Each CCP will have one or more control
30
measures to assure that the identified hazards are prevented, eliminated, or
31
reduced to acceptable levels.
the
consequences
of exposure to the hazard.
Considerations made when
These measures, called
control
measures, are
others
are.
More than one control
Common examples of CCPs include cooking,
Guam Food Code Annex 2 – Management of Food Safety Practices – Achieving Active
Managerial Control of Foodborne Illness Risk Factors
20
1
cooling, hot holding, and cold holding of ready-to-eat potentially hazardous foods
2
(time/temperature control for safety foods). Due to vegetative and spore- and toxin-
3
forming bacteria that are associated with raw animal foods, it is apparent that the
4
proper execution of control measures at each of these operational steps is
5
essential to prevent or eliminate food safety hazards or reduce them to acceptable
6
levels.
7
(2)
8
CCPs are only used to address issues with product safety.
9
the part of the establishment such as first-in first-out (FIFO) or refrigerating non-
10
potentially hazardous foods (time/temperature control for safety foods) are to ensure
11
food quality rather than food safety and therefore should not be considered as
12
CCPs unless they serve a dual-purpose of ensuring food safety.
13
(3)
14
Different facilities preparing similar food items may identify different hazards and
15
the CCPs. This can be due to differences in each facility's layout, equipment,
16
selection of ingredients, and processes employed. In mandatory HACCP systems,
17
there may be rigid regulatory requirements regarding what must be designated a
18
CCP.
19
CCPs or through prerequisite programs. For instance, one facility may decide that
20
it can best manage the hazards associated with cooling through a standardized
21
procedure in its prerequisite programs rather than at a CCP in its HACCP plan.
22
One tool that can be used to assist each facility in the identification of CCPs
23
unique to its operation is a CCP decision tree.
Are quality issues considered when determining CCPs?
Actions taken on
Are the CCPs the same for everyone?
In voluntary HACCP systems,
hazard control may be accomplished at
24
Guam Food Code Annex 2 – Management of Food Safety Practices – Achieving Active
Managerial Control of Foodborne Illness Risk Factors
21
Annex 2 – CCP Decision Tree 1
1
2
1. Do preventive measures exist at this step or subsequent
3
steps for the identified hazard?
4
5
Modify step,
6
Yes
No
process or product
7
8
9
Yes
10
11
12
2. Does this step eliminate or
Is control at this step
13
reduce the likely occurrence of a
necessary for safety?
14
hazard to an acceptable level?
15
16
17
No
18
19
20
3. Could contamination with identified hazards
21
occur in excess of acceptable levels or could
22
these increase to unacceptable levels?
23
24
25
Yes
No
26
27
Yes
28
4. Will a subsequent step eliminate
29
identified hazards or reduce the likely
30
occurrence to an acceptable level?
No
Guam Food Code Annex 2 – Management of Food Safety Practices – Achieving Active
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22
1
2
3
Yes
No
4
5
6
7
Critical
8
Control
9
Point
10
11
STOP
Not a Critical
Control Point
12
13
14
15
16
Decision Tree adapted from NACMCF.
Guam Food Code Annex 2 – Management of Food Safety Practices – Achieving Active
Managerial Control of Foodborne Illness Risk Factors
23
1
(C)
Principle #3: Establish Critical Limits
2
(1)
What is a critical limit and what is its purpose?
3
A critical limit is a prescribed parameter (e.g., minimum and/or maximum value)
4
that must be met to ensure that food safety hazards are controlled at each
5
CCP.
6
operating conditions at a CCP. Each control measure at a CCP has one or
7
more associated critical limits. Critical limits may be based upon factors like
8
temperature, time, moisture level, water activity (a w), or pH. They must be
9
scientifically-based and measurable.
A critical limit is used to distinguish between safe and unsafe
10
(2)
What are examples of critical limits?
11
Examples of critical limits are the time/temperature parameters for cooking
12
chicken (165 oF for 15 seconds). In this case, the critical limit designates the
13
minimum criteria required to eliminate food safety hazards or reduce them to
14
an acceptable level. The critical limit for the acidification of sushi rice, a pH
15
of <4.6, sets the maximum limit for pH necessary to control the growth of
16
spore - and toxin - forming bacteria.
17
regulatory standards
18
guidelines, performance standards, or experimental results.
19
(D)
Principle #4: Establish Monitoring Procedures
20
(1)
What is the purpose of monitoring?
21
Monitoring is the act of observing and making measurements to help
22
determine if critical limits are being met and maintained.
23
determine whether the critical limits that have been established for each
24
CCP are being met.
25
(2)
26
Examples
27
measurements of time, temperature, pH, and water activity.
28
chicken is determined to be a CCP in an operation, then monitoring the
29
internal temperature of a select number of chicken pieces immediately
30
following
such
as
the
Critical limits may be derived from
FDA Food
Code,
other
applicable
It is used to
What are examples of monitoring activities?
of
the
monitoring
cook
step
activities
would
include
visual observations and
If cooking
be an example of a monitoring activity.
Guam Food Code Annex 2 – Management of Food Safety Practices – Achieving Active
Managerial Control of Foodborne Illness Risk Factors
24
1
Alternatively, the temperature of an oven or fryer and the time required to
2
reach an internal temperature of 165 oF could also be monitored.
3
(3)
4
Typically, monitoring activities fall under two broad categories:
How is monitoring conducted?
5
measurements
6
observations
7
Measurements usually involve time and temperature but also include other
8
parameters such as pH. If an operation identifies the acidification of sushi
9
rice as a CCP and the critical limit as the final pH of the product being
10
< 4.6, then the pH of the product would be measured to ensure that the
11
critical limit is met.
12
Observations involve visual inspections to monitor the presence or absence
13
of a food safety activity. If date marking is identified as a CCP in a deli
14
operation for controlling Listeria monocytogenes in ready-to-eat deli meats,
15
then the monitoring activity could involve making visual inspections of the date
16
marking system to monitor the sell, consume, or discard dates.
17
(4)
18
Monitoring can be performed on a continuous or intermittent basis. Continuous
19
monitoring is always preferred when feasible as it provides the most complete
20
information regarding the history of a product at a CCP.
21
temperature and time for an institutional cook-chill operation can be recorded
22
continuously on temperature recording charts.
23
If
24
conducted often enough to make sure that the critical limits are being met.
25
(5)
26
Individuals directly associated with the operation (e.g., the person in charge
27
of the establishment, chefs, and departmental supervisors) are often selected
28
to monitor CCPs. They are usually in the best position to detect deviations
29
and take corrective actions when necessary. These employees should be
30
properly trained in the specific monitoring techniques and procedures used.
How often is monitoring conducted?
intermittent monitoring
is used,
the
For example, the
frequency of monitoring should be
Who conducts monitoring?
Guam Food Code Annex 2 – Management of Food Safety Practices – Achieving Active
Managerial Control of Foodborne Illness Risk Factors
25
1
(E)
Principle #5: Establish Corrective Actions
2
(1)
What are corrective actions?
3
Corrective actions are activities that are taken by a person whenever a
4
critical limit is not met. Discarding food that may pose an unacceptable food
5
safety risk to consumers is a corrective action. However, other corrective
6
actions such as further cooking or reheating a product can be used provided
7
food safety is not compromised. For example, a restaurant may be able to
8
continue cooking hamburgers that have not reached an internal temperature
9
of 155 oF for 15 seconds until the proper temperature is met. Clear
10
instructions should be developed detailing who is responsible for performing
11
the corrective actions, the procedures to be followed, and when.
12
(F)
Principle #6: Establish Verification Procedures
13
(1)
What is verification?
14
Verification includes those activities, other than monitoring, that determine the
15
validity of the HACCP plan and show that the system is operating according
16
to the plan.
17
collecting and evaluating scientific and technical information to determine if
18
the
19
hazards. Clear instructions should be developed detailing who is responsible
20
for conducting verification, the frequency of verification, and the procedures
21
used.
22
(2)
23
Validation is a component of verification which focuses on
HACCP system, when properly implemented, will effectively control the
What is the frequency of verification activities?
What are some
examples of verification activities?
24
Verification activities are conducted frequently, such as daily, weekly,
25
monthly, and include the following:
26
observing the person doing the monitoring and determining
27
whether monitoring is being done as planned
28
reviewing the monitoring records to determine if they are
29
completed accurately and consistently
Guam Food Code Annex 2 – Management of Food Safety Practices – Achieving Active
Managerial Control of Foodborne Illness Risk Factors
26
1
determining whether the records show that the frequency
2
of monitoring stated in the plan is being followed
3
ensuring that corrective action was taken when the
4
person monitoring found and recorded that the critical
5
limit was not met
6
validating that the critical limits are achieving the desired
7
results of controlling the identified hazard
8
confirming that all equipment, including equipment used
9
for monitoring, is operated, maintained, and calibrated
10
properly.
11
(G)
Principle #7: Establish Record Keeping Procedures
12
(1)
Why are records important?
13
Maintaining
14
management system
15
documentation that appropriate corrective actions were taken when
16
critical limits were not met.
17
implicated in a foodborne illness, documentation of activities related to
18
monitoring and corrective actions can provide proof that reasonable care
19
was exercised in the operation of the establishment.
20
activities provides a mechanism for verifying that the activities in the
21
HACCP plan were properly completed.
22
serve a dual purpose of ensuring quality and food safety.
23
(2)
24
documentation
can
of
the
activities
in
be vital to its success.
a
food
Records
safety
provide
In the event that an establishment is
Documenting
In many cases, records can
What types of records are maintained as part of a food safety
management system?
25
There are at least 5 types of records that could be maintained to support a
26
food safety management system:
27
records documenting the activities related to the prerequisite
28
programs
29
monitoring records
30
corrective action records
Guam Food Code Annex 2 – Management of Food Safety Practices – Achieving Active
Managerial Control of Foodborne Illness Risk Factors
27
1
verification and validation records
2
calibration records.
3
4.
THE PROCESS APPROACH – A PRACTICAL APPLICATION OF
HACCP AT RETAIL TO ACHIEVE ACTIVE MANAGERIAL CONTROL
4
5
(A)
Why Focus on HACCP Principles at Retail and Food Service?
6
FDA recognizes that there are important differences between using HACCP
7
principles
8
manufacturing plants and applying these same principles in food safety
9
management
in
a
food
system
safety
developed
management system developed for food
for
use
in
retail
and
food service
10
establishments.
11
Since the 1980’s, operators and regulators have been exploring the use of
12
the HACCP principles in restaurants, grocery stores, institutional care
13
facilities, and other retail food establishments.
14
been learned about how these principles can be used in these varied
15
operations, collectively referred to as retail food establishments. Most of this
16
exploration has centered around the focal question of how to stay true to
17
the NACMCF definitions of HACCP and still make the principles useful to an
18
industry that encompasses the broadest range of conditions.
19
Unlike industries such as canning, other food processing, and dairy plants,
20
the retail industry is not easily defined by specific commodities or conditions.
21
Consider the following characteristics that retail food establishments share
22
that set them apart from most food processors:
23
1.
During this time, much has
Employee and management turnover is exceptionally high in food
24
establishments, especially for entry level positions.
25
many employees or managers have little experience and food safety
26
training must be continuously provided.
27
2.
This means the
Many establishments are start-up businesses operating without benefit
28
of a large corporate support structure and having a relatively low profit
29
margin and perhaps less capital to work with than other segments of
30
the food industry.
Guam Food Code Annex 2 – Management of Food Safety Practices – Achieving Active
Managerial Control of Foodborne Illness Risk Factors
28
1
3.
There is an almost
endless number of production techniques,
2
products, menu items, and ingredients used which are not easily
3
adapted
4
frequently and little preparation time is available.
to
a
simple,
standardized
approach.
Changes
occur
5
FDA fully recognizes the diversity of retail and food service establishments
6
and their varying in-house resources to implement HACCP. That recognition
7
is combined with an understanding that the success of such implementation
8
is dependent upon establishing realistic and useful food safety strategies that
9
are customized to the operation.
10
(B)
What is the Process Approach?
11
When conducting the hazard analysis, food manufacturers usually use food
12
commodities as an organizational tool and follow the flow of each product.
13
This is a very useful approach for producers or processors since they are
14
usually handling one product at a time.
15
service operations, foods of all types are worked together to produce the
16
final
17
necessary.
18
processes common to a specific operation is often more efficient and useful
19
for retail and food service operators. This is called the “ process approach”
20
to HACCP.
21
The process approach can best be described as dividing the many food
22
flows in an establishment into broad categories based on activities or stages
23
in
24
managerial controls on each grouping.
25
(C)
product.
the
By contrast, in retail and food
This makes a different approach to the hazard analysis
Conducting the hazard analysis by using the food preparation
preparation
of the food, then analyzing the hazards, and placing
What are the three food preparation processes most often used
26
in retail and food service establishments and how are they
27
determined?
28
The flow of food in a retail or food service establishment is the path that
29
food follows from receiving through
30
Several activities or stages make up the flow of food and are called
service or sale to the consumer.
Guam Food Code Annex 2 – Management of Food Safety Practices – Achieving Active
Managerial Control of Foodborne Illness Risk Factors
29
1
operational steps. Examples of operational steps include receiving, storing,
2
preparing, cooking, cooling, reheating, holding, assembling, packaging, serving,
3
and selling.
4
food service and retail food store operations.
5
Most food items produced in a retail or food service establishment can be
6
categorized into one of three preparation processes based on the number of
7
times the food passes through the temperature danger zone between 41°F
8
and 135°F:
9
The terminology used for operational steps may differ between
Process 1: Food Preparation with No Cook Step
10
Example flow: Receive – Store – Prepare – Hold – Serve
11
(other food flows are included in this process, but there is no cook
12
step to destroy pathogens)
13
Process 2: Preparation for Same Day Service
14
Example flow: Receive – Store – Prepare – Cook – Hold – Serve
15
(other food flows are included in this process, but there is only one
16
trip through the temperature danger zone)
17
Process 3: Complex Food Preparation
18
Example flow: Receive – Store – Prepare – Cook – Cool – Reheat – Hot
19
Hold – Serve
20
(other food flows are included in this process, but there are always
21
two or more complete trips through the temperature danger zone)
22
A summary of the three food preparation processes in terms of number of
23
times through the temperature danger zone can be depicted in a Danger
24
Zone diagram.
25
danger zone, they do not pass all the way through it.
26
through the danger zone only once are classified as Same Day Service,
27
while foods that go through more than once are classified as Complex food
28
preparation.
Although foods produced using process 1 may enter the
Foods that go
29
Guam Food Code Annex 2 – Management of Food Safety Practices – Achieving Active
Managerial Control of Foodborne Illness Risk Factors
30
Complete Trips Through the Danger Zone
135°F
2
0
1
1
3
41°F
No Cook
Same Day
Complex
1
2
The three food preparation processes conducted in retail and food service
3
establishments are not intended to be all-inclusive. For instance, quick service
4
facilities may have “cook and serve” processes specific to their operation.
5
These
6
preparation processes in full service restaurants since many of their foods
7
are generally cooked and hot held before service. In addition, in retail food
8
stores, operational steps such as packaging and assembly may be included
9
in
all
processes
of
are likely to be different from the “Same Day Service”
the food preparation processes before the product is sold to the
10
consumer. It is also very common for a retail or food service operator to
11
use multiple food preparation processes to create a single menu item.
12
(D)
13
In the process approach to HACCP, conducting a hazard analysis on
14
individual food items is time and labor intensive and is generally unnecessary.
15
Identifying and controlling the hazards in each food preparation process
16
achieves the same control of risk factors as preparing a HACCP plan for
17
each individual product.
18
Example: An establishment has dozens of food
How is a hazard analysis conducted in process HACCP?
items (including baked
Guam Food Code Annex 2 – Management of Food Safety Practices – Achieving Active
Managerial Control of Foodborne Illness Risk Factors
31
1
chicken and baked meatloaf) in the “Preparation for Same Day Service”
2
category.
3
of the individual hazards, control via proper cooking and holding
will
4
generally ensure the safety of all
An
5
illustration of this concept follows:
Each of the food items may have unique hazards, but regardless
though
they
of the foods in this category.
6
Even
have unique hazards, baked chicken and
7
meatloaf are items frequently grouped in the “Same Day
8
Service” category (Process 2).
9
Salmonella spp. and Campylobacter, as well as spore-formers,
10
such as Bacillus cereus
11
significant biological hazards in chicken.
12
Significant biological hazards in meatloaf include Salmonella
13
spp.,
14
perfringens.
15
Despite their different hazards, the control measure used to kill
16
pathogens in both these products is cooking to the proper
17
temperature.
18
Additionally, if the products are held after cooking, then proper
19
hot holding or time control is also required to prevent the
20
outgrowth of spore-formers that are not destroyed by cooking.
21
As with product-specific HACCP, critical limits for cooking remain specific to
22
each food item in the process. In the scenario described above, the cooking
23
step for chicken requires a final internal temperature of 165°F for 15
24
seconds to control the pathogen load for Salmonella spp. Meatloaf, on the
25
other hand, is a ground beef product and requires a final internal
26
temperature of 155°F for 15 seconds to control the pathogen load for both
27
Salmonella
28
refrigerated storage or hot holding have critical limits that apply to all foods.
E.
coli
spp. and E. coli
and Clostridium
O157:H7,
O157:H7.
perfringens, are
Bacillus cereus, and Clostridium
Some operational steps such as
29
30
Guam Food Code Annex 2 – Management of Food Safety Practices – Achieving Active
Managerial Control of Foodborne Illness Risk Factors
32
1
Annex 2, Table 4 further illustrates this concept. Note that the only unique
2
control measure applies to the critical limit of the cooking step for each of
3
the products. Other food safety hazards and control measures may exist
4
that
are
not
depicted
Guam Food Code Annex 2 – Management of Food Safety Practices – Achieving Active
Managerial Control of Foodborne Illness Risk Factors
33
here:
1
Annex 2, Table 4: Examples of Hazards and Control Measures for Same
2
Day Service Items
3
Process 2: Preparation for Same Day Service
4
Example Products
Baked Meatloaf
Baked Chicken
5
Example Biological
Salmonella spp.
Salmonella spp.
6
Hazards
E. coli O157:H7
Campylobacter
7
Clostridium perfringens
Clostridium perfringens
8
Bacillus cereus
Bacillus cereus
9
Various fecal-oral route
Various fecal-oral route
pathogens
pathogens
10
11
Example Control Measures
o
Refrigeration at 41 F or below
o
Refrigeration at 41 F or below
12
13
Cooking at 155 F for 15
Cooking at 165 F for 15
14
seconds
seconds
o
o
15
16
Hot Holding at 135 F or above
Hot Holding at 135 F or above
17
OR Time Control
OR Time Control
19
Good personal hygiene (No
Good personal hygiene (No
20
bare hand contact with RTE
bare hand contact with RTE
21
food, proper handwashing,
food, proper handwashing,
22
exclusion/restriction of ill
exclusion/restriction of ill
23
employees)
employees)
o
o
18
24
RTE = ready-to-eat food
25
26
27
(E)
How is the process approach helpful to industry in determining
28
the measures that must be implemented to actively manage the
29
foodborne illness risk factors that result in out-of-control hazards?
30
Even though variations in foods and in the three food preparation process
Guam Food Code Annex 2 – Management of Food Safety Practices – Achieving Active
Managerial Control of Foodborne Illness Risk Factors
34
1
flows used to prepare them are common, the control measures will generally
2
be
3
temperature danger zone. Several of the most common control measures
4
associated with each food preparation process are discussed in this Annex.
5
Retail or food service establishments should use these simple control
6
measures as the core of their food safety management systems; however,
7
there may be other risk factors unique to an operation or process that are
8
not listed here.
9
In developing a voluntary food safety management system, active managerial
the
same based on the number of
of
times the food goes through
the
Each operation should be evaluated independently.
10
control
risk
factors
common
to
each process can be achieved by
11
implementing control measures at certain operational steps designated as
12
critical control points (CCPs) or by implementing prerequisite programs. This
13
is explained in more detail in the Operator’s Manual discussed in Part 5 of
14
this Annex.
15
(F)
16
In order to have active managerial control over personal hygiene and cross-
17
contamination, certain control measures must be implemented in all phases
18
of
19
implemented regardless of the food preparation process used:
Facility-wide Considerations
the
operation.
All
of
the
following
control
measures should be
20
No
bare hand contact with ready-to-eat foods (or use of a pre-
21
approved, alternative procedure) to help prevent the transfer of
22
viruses, bacteria, or parasites from hands to food
23
Proper handwashing to help prevent the transfer of viruses, bacteria,
24
or parasites from hands to food
25
Restriction or exclusion of ill employees to help prevent the
26
transfer of viruses, bacteria, or parasites from hands to food
27
Prevention of cross-contamination of ready-to-eat food or clean and
28
sanitized food-contact surfaces with soiled cutting boards, utensils,
29
aprons, etc., or raw animal foods.
Guam Food Code Annex 2 – Management of Food Safety Practices – Achieving Active
Managerial Control of Foodborne Illness Risk Factors
35
1
2
(G)
Food Preparation Process 1 – Food Preparation with No Cook Step
Example Flow: RECEIVE
STORE
PREPARE
HOLD
SERVE
3
Several food flows are represented by this particular process.
4
these food flows are common to both retail food stores and food service
5
facilities, while others only apply to retail operations. Raw, ready-to-eat food
6
like
7
Components of these foods are received raw and will not be cooked before
8
consumption.
9
Foods cooked at the processing level but that undergo no further cooking at
10
the retail level before being consumed are also represented in this category.
11
Examples of these kinds of foods are deli meats, cheeses, and other
12
pasteurized dairy products (such as yogurt).
13
received and sold raw but are to be cooked by the consumer after
14
purchase, e.g., hamburger meat, chicken, and steaks, are also included in
15
this category.
16
All the foods in this category lack a cook step while at the retail or food
17
service facility; thus, there are no complete trips through the danger zone.
18
Purchase
19
establishment to ensure that foods are received as safe as possible.
20
Without a kill step to destroy pathogens, preventing further contamination by
21
ensuring that employees follow good hygienic practices is an important
22
control measure.
23
Cross-contamination must be prevented by properly storing ready-to-eat food
24
away from raw animal foods and soiled equipment and utensils. Foodborne
25
illness may result from ready-to-eat food being held at unsafe temperatures
26
for long periods of time due to the outgrowth of bacteria.
27
In addition to the facility-wide considerations, a food safety management
28
system involving this food preparation process should focus on ensuring
29
active managerial control over the following:
30
sashimi,
raw
oysters,
specifications
can
and
be
salads
required
are
Many of
grouped in this category.
In addition, foods that are
by
the
retail or food service
Cold holding or using time alone to control bacterial growth
Guam Food Code Annex 2 – Management of Food Safety Practices – Achieving Active
Managerial Control of Foodborne Illness Risk Factors
36
1
and toxin production
2
Food source (e.g., shellfish due to concerns with viruses, natural
3
toxins, and Vibrio and for certain marine finfish intended for raw
4
consumption due to concerns with ciguatera toxin)
5
Receiving temperatures (e.g., certain species of marine finfish
6
due to concerns with scombrotoxin)
7
Date marking of ready-to-eat PHF (TCS food) held for more
8
than 24 hours to control the growth of psychrophiles such as
9
Listeria monocytogenes
10
Freezing certain species of fish intended for raw consumption
11
due to parasite concerns
12
Cooling from ambient temperature to prevent the outgrowth of
13
spore-forming or toxin-forming bacteria.
14
(H)
Food Preparation Process 2 – Preparation for Same Day Service
15
Example Flow: RECEIVE
16
In this food preparation process, food passes through the danger zone only
17
once in the retail or food service facility before it is served or sold to the
18
consumer.
19
chicken, but can also be cooked and served immediately. In addition to the
20
facility-wide considerations, a food safety management system involving this
21
food preparation process should focus on ensuring active managerial control
22
over the following:
STORE
PREPARE
COOK
HOLD
SERVE
Food is usually cooked and held hot until served, e.g., fried
23
Cooking to destroy bacteria and parasites
24
Hot holding or using time alone to prevent the outgrowth of
25
spore-forming bacteria.
26
Approved food source, proper receiving temperatures, and proper cold
27
holding before cooking would also be important if dealing with certain marine
28
finfish due to concerns with ciguatera toxin and scombrotoxin.
Guam Food Code Annex 2 – Management of Food Safety Practices – Achieving Active
Managerial Control of Foodborne Illness Risk Factors
37
1
(I)
Food Preparation Process 3 – Complex Food Preparation
2
Example Flow: RECEIVE
3
REHEAT
STORE
PREPARE
HOT HOLD
COOK
COOL
SERVE
4
Foods prepared in large volumes or in advance for next day service usually
5
follow an extended process flow. These foods pass through the temperature
6
danger zone more than one time; thus, the potential for the growth of spore-
7
forming or toxigenic bacteria is greater in this process.
8
adequately control food product temperatures is one of the most frequently
9
encountered risk factors contributing to foodborne illness.
10
should minimize the time foods are at unsafe temperatures.
11
In addition to the facility-wide considerations, a food safety management
12
system involving this food preparation process should focus on ensuring
13
active managerial control over the following:
Failure to
Food handlers
14
Cooking to destroy bacteria and parasites
15
Cooling to prevent the outgrowth of spore-forming or toxin-
16
forming bacteria
17
Hot and cold holding or using time alone to control bacterial
18
growth and toxin formation
19
Date marking of ready-to-eat PHF (TCS food) held for more
20
than 24 hours to control the growth of psychrophiles such as
21
Listeria monocytogenes
22
Reheating for hot holding, if applicable.
23
Approved food source, proper receiving temperatures, and proper cold
24
holding before cooking would also be important if dealing with certain marine
25
finfish due to concerns with ciguatera toxin and scombrotoxin.
26
5.
FDA RETAIL HACCP MANUALS
27
(A)
What guidance has been developed by FDA to assist operators of
28
retail
29
managerial control of foodborne illness risk factors?
30
and
food
service
establishments
in
achieving
active
FDA, in partnership with Federal, State, and local regulators, industry,
Guam Food Code Annex 2 – Management of Food Safety Practices – Achieving Active
Managerial Control of Foodborne Illness Risk Factors
38
1
academia, and consumers, has written a guidance document entitled,
2
“Managing Food Safety:
A Manual for the Voluntary Use of HACCP
3
Principles
of
4
Commonly referred to as the “Operator’s Manual,” this document is designed
5
to assist operators with developing or enhancing food safety management
6
systems based on the process approach to HACCP. The manual presents a
7
step-by-step procedure for writing and voluntarily implementing a food safety
8
management system based on the principles of HACCP. The desired outcome is
9
an operator who employs a preventive rather than a reactive strategy to food
for
Operators
Food
Service
and
Retail Establishments.”
10
safety.
11
The Operator’s Manual embodies FDA’s current thinking on the application
12
of HACCP principles at retail. It advocates the voluntary use of HACCP
13
principles using the process approach as a practical and effective means of
14
reducing the occurrence of foodborne illness risk factors leading to out-of-
15
control
16
implementation of HACCP principles at retail and should not be used to
17
develop
18
regulations, ordinances, or laws.
19
website at http://www.cfsan.fda.gov/~tcjm/hret2toc.html.
20
(B)
hazards.
The
Operator’s Manual is strictly for the voluntary
HACCP plans that are required through Federal, State, or local
The document can be found on the FDA
What guidance has been developed by FDA to assist regulators
21
of retail and food service establishments in assessing industry’s
22
active managerial control of foodborne illness risk factors?
23
FDA has written a document for regulators of retail and food service
24
establishments
25
Applying
26
Inspections and Evaluating Voluntary Food Safety Management Systems.”
27
Commonly referred to as the “Regulator’s Manual,” this document was written
28
to provide a risk-based inspectional “roadmap” for evaluating the degree of
29
active managerial control an operator has over foodborne illness risk factors.
entitled,
HACCP
“Managing Food Safety: A Regulator’s Manual for
Principles
to
Risk-Based
Retail
and
Food
Service
30
Guam Food Code Annex 2 – Management of Food Safety Practices – Achieving Active
Managerial Control of Foodborne Illness Risk Factors
39
1
In addition, the manual advocates the use of voluntary intervention strategies,
2
including the development of food safety management systems or risk control
3
plans to bring about a long-term behavior change that will result in a
4
reduction in the occurrence of risk factors. In cases where an operator may
5
want their inspector to provide them with feedback on their voluntarily-
6
implemented food safety management system, the manual provides regulators
7
with information on how to validate and verify an existing system.
8
The
9
http://www.cfsan.fda.gov/~tcjm/hret3toc.html.
document
can
be
found
on
the
FDA
website
at:
10
Annex 3 of the Guam Food Code outlines the basis for conducting
11
successful risk-based inspections and is provided to assist industry in
12
achieving active managerial control of foodborne illness risk factors as
13
outlined in the draft Recommended National Retail Food Regulatory Program
14
Standards and the Regulator’s Manual.
15
6.
ADVANTAGES OF USING THE PRINCIPLES OF HACCP
16
(A)
What advantages does using HACCP principles offer operators of
17
retail and food service establishments?
18
Rather than relying solely on periodic feedback from inspections by regulatory
19
agencies,
20
management system based on HACCP principles emphasizes continuous
21
problem
22
encourages communication between industry and regulators.
23
A food safety management system based on HACCP principles offers many
24
other advantages to industry.
25
provide a method for achieving active managerial control of multiple risk
26
factors associated with an entire operation.
an
establishment
solving
and
operator
prevention.
who
implements
a
food
safety
Additionally, HACCP enhances and
One advantage is that such a system may
27
Reduction in product loss
28
Increase in product quality
Other advantages include:
Guam Food Code Annex 2 – Management of Food Safety Practices – Achieving Active
Managerial Control of Foodborne Illness Risk Factors
40
1
Better inventory control
2
Consistency in product preparation
3
Increase in profit
4
Increased employee awareness and participation in food safety
5
(B)
What advantages does using HACCP principles offer regulators of
retail and food service establishments?
6
7
Traditional
inspections
8
reactive rather than preventive
9
techniques allows
for
are
a
relatively resource-intensive, inefficient, and
in nature.
satisfactory
Using traditional inspection
“snapshot”
assessment
of
the
10
requirements of the code at the time of the inspection. Unfortunately, unless an
11
inspector asks questions and inquires about the activities and procedures
12
being utilized by the establishment even at times when the inspector is not
13
there, there is no way to know if an operator is achieving active managerial
14
control.
15
With the limited time often available for conducting inspections, regulators
16
must focus their attention on those areas that clearly have the greatest
17
impact on food safety – foodborne illness risk factors.
18
there are only a few control measures that are essential to food safety and
19
focusing on these during the inspection, an inspector can assess the
20
operator’s active managerial control of the foodborne illness risk factors.
21
Regulators can provide invaluable feedback to an operator through their
22
routine inspections.
23
approach.
24
inspector can provide an operator with the constructive input needed to
25
establish the control system necessary to bring the foodborne illness risk
26
factors back under continuous control.
27
7.
28
In order to make a positive impact on foodborne illness, retail and food
29
service operators must achieve active managerial control of the risk factors
30
contributing to foodborne illness.
By knowing that
This is especially useful when utilizing a risk-based
By incorporating HACCP principles into routine inspections, an
SUMMARY
Combined with basic sanitation, employee
Guam Food Code Annex 2 – Management of Food Safety Practices – Achieving Active
Managerial Control of Foodborne Illness Risk Factors
41
1
training, and other prerequisite programs, the principles of HACCP provide
2
an effective system for achieving this objective.
3
The goal in applying HACCP principles in retail and food service is to have
4
the operator take purposeful actions to ensure safe food.
5
approach simplifies HACCP principles for use in retail and food service. This
6
practical and effective method of hazard control embodies the concept of
7
active managerial control by providing an on-going system of simple control
8
measures that will reduce the occurrence of risk factors that lead to out-of-
9
control hazards.
The process
10
The role of retail and food service regulatory professionals is to conduct
11
risk-based inspections using HACCP principles to assess the degree of control
12
industry has over the foodborne illness risk factors. Regulators can assist
13
industry in achieving active managerial control of risk factors by using a risk-
14
based
15
suggesting possible solutions and improvements.
16
8.
17
Much of this Annex is adapted from the National Advisory Committee on
18
Microbiological Criteria for Foods, Hazard Analysis and Critical Control Point
19
Principles and Guidelines, adopted August 14, 1997.
20
The physical hazards table (Table 3) was provided courtesy of “Overview of
21
Biological, Chemical, and Physical Hazards” in “HACCP Principles and
22
Applications,” Merle Pierson and Donald A. Corlett, Jr. (Eds.), 1992. p. 8-28.
23
Chapman and Hall, New York.
24
Based
25
Conference for Food Protection, the two HACCP Manuals have been
26
endorsed by the Conference.
inspection
approach
to
identify
strengths
and weaknesses and
ACKNOWLEDGEMENTS
on
a
recommendation from the Retail HACCP Committee of the
27
28
9.
RESOURCES AND REFERENCES
29
(A)
Articles
30
Bryan, Frank “Hazard Analyses of Street Foods
Guam Food Code Annex 2 – Management of Food Safety Practices – Achieving Active
Managerial Control of Foodborne Illness Risk Factors
42
1
and Considerations for Food Safety.” Dairy, Food
2
and Environmental Sanitation, February 1995, pp.
3
64-69.
4
Bryan,
5
Future in Contribution to Food Safety.” Dairy, Food
6
& Environmental Sanitation, November 1994, pp.
7
650-655.
8
Bryan,
9
Agencies to Institute a Hazard Analysis Critical
Frank “HACCP:
Present
Status
and
Frank “Procedures for Local Health
10
Control
11
Assurance in Food Service Operations.” Journal
12
of
13
241-245.
Point
Program
for
Food
Safety
Environmental Health, March/April 1985, pp.
14
15
Bryan, Frank “Hazard Analysis of Food Service
16
Operation.” Food Technology, February 1981, pp.
17
78-87.
18
Bryan, Frank “Hazard Analysis Critical Control
19
Point Approach: Epidemiologic Rationale and
20
Application to Food Service Operations.” Journal
21
of Environmental Health, August 1981, pp. 7-14.
22
23
Bryan, Frank
“Factors
that
Contribute to
24
Outbreaks of Foodborne Disease.” Journal of
25
Food Protection, October 1978, pp. 816-827.
26
27
Briley and Klaus “Using Risk Assessment as a
28
Method of Determining Inspection Frequency.”
29
Dairy and Food Sanitation, December 1985, pp.
Guam Food Code Annex 2 – Management of Food Safety Practices – Achieving Active
Managerial Control of Foodborne Illness Risk Factors
43
1
468-474.
2
3
Centers for Disease Control and Prevention.
4
Surveillance for Foodborne Disease Outbreaks –
5
United States, 1993-1997. Morbidity Mortality
6
Weekly Report, #49 (SS01), USPHS, March 17,
7
2000, pp. 1-51.
8
9
Mead, P.S., Slutsker, L., Dietz, V., McCraig, L.F.,
10
Bresee, J.S., Shapiro, C., Griffin, P.M., Tauxe, R.V.
11
“Food-related Illness and Death in the United
12
States.” Emerg. Infect. Dis. Vol. 5, No. 5, 1999.
13
Found at:
14
http://www.cdc.gov/ncidod/EID/vol5no5/mead.htm.
15
16
National Advisory Committee on Microbiological
17
Criteria
18
Analysis and Critical Control Point System,
19
USDA - FSIS Information Office, 1997.
for
Food (NACMCF).
1997 Hazard
20
21
National Advisory Committee on Microbiological
22
Criteria
23
Analysis and Critical Control Point System, Int. J.
24
Food Microbiology, 16:1-23.
for
Food
(NACMCF). 1992 Hazard
25
26
National
Food
Processors
Assoc.
“HACCP
27
Implementation:
28
Foods.” Journal of Food Protection, December,
29
1993, pp. 1077-1084.
A Generic Model for Chilled
30
Guam Food Code Annex 2 – Management of Food Safety Practices – Achieving Active
Managerial Control of Foodborne Illness Risk Factors
44
1
President’s Council on Food Safety.
2
Safety Strategic Plan, 2001. Ch. 2: Vision, Goals,
3
Objectives,
4
http://www.foodsafety.gov/~fsg/cstrpl-4.html#chap2.
and
Action
items.
The Food
Found
at:
5
6
Silliker, John, Ph.D. “Microbiological Testing and
7
HACCP
8
Environmental Sanitation, October 1995, pp. 606-
9
610.
Programs.”
Dairy,
Food
and
10
11
Stier, R.F., and Blumenthal, M.M., Ph.D.
“Will
12
HACCP be Carrot or Stick.”
13
Environmental Sanitation, October 1995, pp. 616 -
14
620.
Dairy, Food and
15
16
Tisler, J.M. “The Food and Drug Administration’s
17
Perspective on HACCP,” Food Technology, June
18
1991, pp. 125-127.
19
20
Tompkin, R.B.
21
Production
22
Journal of Food Protection, September 1990, pp.
23
795-803.
of
“The Use of HACCP in the
Meat
and
Poultry Products.”
24
25
Weingold, S.E., et al. “Use of Foodborne Disease
26
Data for HACCP Risk Assessment.”
27
Food Protection, September 1994, pp. 820-830.
Journal of
28
29
30
(B)
Books
Corlett,
D.A.
and
Pierson, M.D.
HACCP,
Guam Food Code Annex 2 – Management of Food Safety Practices – Achieving Active
Managerial Control of Foodborne Illness Risk Factors
45
1
Principles & Applications, ed., Chapman and Hall,
2
New York, 1992.
3
4
Diseases Transmitted by Foods, 2nd ed., Centers
5
for Disease Control, USPHS, 1982.
6
7
Fellows, P.J.
Food Processing Technology,
8
Principles and Practice, Ellis Horwood, New York,
9
1990.
10
11
Fennema, O.R. Food Chemistry, 2nd ed., Marcel
12
Dekker, Inc., New York, 1985.
13
14
Foodborne Diseases, ed. D.O. Cliver, Academic
15
Press, San Diego, California, 1990.
16
17
HACCP Reference Book, National Restaurant
18
Assoc., The Educational Foundation, Chicago,
19
1994.
20
21
Heymann, David L. MD, (Ed.), 2004. Control of
22
Communicable Diseases Manual, 18th Ed.,
23
American Public Health Association, Washington D.C.
24
25
Jay, J.M. Modern Food Microbiology, 4th ed., Van
26
Nostrand Reinhold, New York, 1992.
27
28
Potter, N.N., J.H. Hotchkiss, 1999. Food Science,
29
5th ed., Kluwer Academic Publishers, Secaucus, NJ.
30
Guam Food Code Annex 2 – Management of Food Safety Practices – Achieving Active
Managerial Control of Foodborne Illness Risk Factors
46
1
Stevenson, K.E., D.T. Bernard, 1999. HACCP: A
2
Systematic Approach to Food Safety, 3rd ed., Food
3
Processors Institute, Washington, DC, 1999.
4
5
6
(C)
FDA Publications
7
Fish and Fishery Products - Code of Federal
8
Regulations, Title 21, Part 123 Fish and Fishery
9
Products.
10
11
Fish and Fishery Products Hazards and Controls
12
Guide, Third Edition, June 2001. Food and Drug
13
Administration,
14
purchased from:
Washington,
D.C.
May
be
15
16
National Technical Information Service
17
U.S. Department of Commerce
18
703-487-4650.
19
20
The Fish and Fishery Products Hazards and
21
Controls Guide is also available electronically at
22
http://www.cfsan.fda.gov/~comm/haccpsea.html.
23
Single copies may be obtained as long as supplies
24
last from FDA district offices and from:
25
26
U.S. Food and Drug Administration
27
Office of Seafood
28
5100 Paint Branch Parkway
29
College Park, MD 20740-3835
30
Guam Food Code Annex 2 – Management of Food Safety Practices – Achieving Active
Managerial Control of Foodborne Illness Risk Factors
47
1
Food and Drug Administration/U.S. Public Health
2
Service, 2003. National Shellfish Sanitation Program
3
Guide for the Control of Molluscan Shellfish,
4
found at http://www.cfsan.fda.gov/~ear/nss2orpd.html.
5
6
Report of the FDA Retail Food Program Database of
7
Foodborne Illness Risk Factors, 2000.The Baseline
8
Report is available from FDA through the following
9
website http://www.cfsan.fda.gov/~dms/retrsk.html.
10
11
FDA Report on the Occurrence of Foodborne Illness Risk
12
Factors in Selected Institutional Foodservice, Restaurant,
13
and Retail Food Store Facility Types (2004). This second
14
report is available from FDA through the following
15
website http://www.cfsan.fda.gov/~dms/retrsk2.html .
16
17
18
19
20
21
22
23
Guam Food Code Annex 2 – Management of Food Safety Practices – Achieving Active
Managerial Control of Foodborne Illness Risk Factors
48
1
Guam Annex
2
3
3
1.
PURPOSE AND SCOPE
4
2.
RISK-BASED ROUTINE INSPECTIONS
5
3.
WHAT IS NEEDED TO PROPERLY CONDUCT A RISK-BASED
Conducting Risk- Based Inspections
INSPECTION?
6
7
4.
RISK-BASED INSPECTION METHODOLOGY
8
5.
ACHIEVING ON-SITE AND LONG-TERM COMPLIANCE
9
6.
INSPECTION FORM AND SCORING
10
7.
CLOSING CONFERENCE
11
8.
SUMMARY
13
1.
PURPOSE AND SCOPE
14
This Annex provides regulatory program managers and front-line inspection
15
staff with guidance on planning, scheduling, conducting, and evaluating
16
risk-based inspections. The draft FDA’s Recommended National Retail
17
Food
18
2003)
19
recommendations to assist regulatory program managers in the planning
20
and development of a risk-based inspection program.
21
The primary focus of this Annex is to provide inspectors with methods for
22
conducting risk-based inspections. Various strategies that can be used by
23
regulatory professionals to assist operators in achieving active managerial
24
control of foodborne illness risk factors are also included in this Annex.
25
As presented in Annex 2 of the Guam Food Code, the Centers for
26
Disease Control and Prevention (CDC) Surveillance Report for 1993-1997,
27
“Surveillance
28
(http://www.cdc.gov/mmwr/preview/mmwrhtml/ss4901a1.htm)
29
most frequently reported contributing factors to foodborne illness.
30
these broad categories of contributing factors directly relate to food safety
12
Regulatory
Program
Standards
(Program Standards) (revised April
(http://www.cfsan.fda.gov/~dms/ret-toc.html)
for
Foodborne
Disease
Outbreaks
provide
–
Guam Food Code Annex 3 – Conducting Risk-based Inspections
1
additional
United
States”
identifies
the
Five of
1
concerns within retail and food service establishments and are collectively
2
termed by the FDA as “foodborne illness risk factors.”
3
categories are:
4
Food from Unsafe Sources
5
Inadequate Cooking
6
Improper Holding Temperatures
7
Contaminated Equipment
8
Poor Personal Hygiene.
9
The
FDA
manual,
HACCP
Managing
Food
Principles
to
Safety:
A
These five broad
Regulator’s Manual for
10
Applying
11
Inspections
12
(FDA’s
13
provides additional information on conducting risk-based inspections. Annex
14
2 of the Guam Food Code provides additional information on Hazard
15
Analysis
16
approach to HACCP.
17
found in this Annex to better prepare for performing risk-based inspections.
18
The “Retail Food Program Resource Guide,” a CD-ROM containing pertinent
19
FDA documents referenced in this Annex, is available for use by federal,
20
state, local, and tribal regulatory agencies. It is produced by and available
21
through FDA Regional Retail Food Specialists or the FDA Division of
22
Federal-State Relations (HFC-150); U.S. Food and Drug Administration;
23
5600 Fishers Lane, Room 12-07; Rockville, Maryland 20857; PHONE (301)
24
827-6906; (FAX) (301) 443-2143.
and
Evaluating Voluntary Food Safety Management Systems
Regulator’s
and
Risk-based Retail and Food Service
Manual)
(http://www.cfsan.fda.gov/~dms/hret3toc.html),
Critical Control Point (HACCP) principles and the process
It should be reviewed in conjunction with the material
25
26
2.
RISK-BASED ROUTINE INSPECTIONS
27
Inspections have been a part of food safety regulatory activities since the
28
earliest days of public health. The term “routine inspection” has been used
29
to
30
regulatory scheme.
describe
periodic
inspections
conducted
as
part
of
Guam Food Code Annex 3 – Conducting Risk-based Inspections
2
an
on-going
1
Program managers should strive to have adequate staffing and resources
2
to allow all inspectors ample time to thoroughly evaluate establishments
3
and ask as many questions as needed to fully understand establishments’
4
operations.
5
limited time in which to complete inspections.
6
need to thoroughly identify and assess the control of foodborne illness risk
7
factors during each inspection.
8
It
9
inspections in a limited timeframe. Even with limited time, inspectors can
10
focus their inspections on assessing the degree of active managerial
11
control an operator has over the foodborne illness risk factors.
12
focusing inspections on the control of foodborne illness risk factors,
13
inspectors can be assured that they are making a great impact on
14
reducing foodborne illness.
15
As described in Annex 2, active managerial control means the purposeful
16
incorporation of specific actions or procedures by industry management
17
into the operation of their businesses to attain control over foodborne
18
illness risk factors.
19
food safety through a continuous system of monitoring and verification.
20
Developing and implementing food safety management systems to prevent,
21
eliminate, or reduce the occurrence of foodborne illness risk factors is
22
recommended to achieve active managerial control. Regulatory inspections
23
and follow-up activities must be proactive by using an inspection process
24
designed to evaluate the implementation of Food Code interventions and
25
the
26
operators have over foodborne illness risk factors. The five Food Code
27
interventions
28
Code and they are just as important today as they were in 1993. They
29
encompass a wide-range of control measures specifically designed to
30
protect consumer health:
31
is
a
For most jurisdictions, however, inspectors continue to have
false
degree
assumption
of
that
inspectors
This does not negate the
cannot
conduct
risk-based
By
It embodies a preventive rather than reactive approach to
active
managerial
control
that
retail
and
foodservice
below were new interventions introduced with the 1993 Food
Demonstration of Knowledge
Guam Food Code Annex 3 – Conducting Risk-based Inspections
3
1
Implementation of Employee Health Policies
2
Hands as a Vehicle of Contamination
3
Time/Temperature Relationships
4
Consumer Advisory.
5
When Food Code interventions are not being implemented or if behaviors,
6
activities, or procedures likely to cause foodborne illness are observed,
7
inspectors should verify that the operator takes immediate corrective action
8
so that consumers do not become sick or injured.
9
the day of the inspection, as well as information gained about the
10
behaviors, activities, and procedures that occur at other times, allow
11
inspectors to assess the strengths and weaknesses of the food safety
12
management system that is in place.
13
An operator should be made aware of the inspectional findings both
14
during,
15
achieving compliance in the future should be discussed. Corrective actions
16
taken during the inspection and repeat violations should be noted on the
17
inspection report.
18
enforcement actions.
19
The inspection process is also an opportunity to educate the operator on
20
the public health reasons supporting the Code requirements.
21
are afforded the chance to ask questions about general food safety
22
matters, they may clearly understand the public health significance of non-
23
compliance.
24
Lastly, if the operator demonstrates a history of violations related to
25
foodborne illness risk factors, the inspection process can be used to assist
26
the operator with implementing long-term control systems to prevent those
27
risk factors from occurring in the future.
and
at
the
conclusion
of,
Observations made on
the inspection
and
strategies
for
Repeat violations should trigger further compliance and
If operators
28
29
3.
INSPECTION?
30
31
WHAT IS NEEDED TO PROPERLY CONDUCT A RISK-BASED
A.
Schedule Inspections Based on Risk
Guam Food Code Annex 3 – Conducting Risk-based Inspections
4
1
Studies have shown that the types of food served, the food preparation
2
processes used, the volume of food, and the population served all has a
3
bearing on the occurrence of foodborne illness risk factors in retail and
4
foodservice establishments.
5
that regulatory jurisdictions develop and use a process that groups food
6
establishments into at least three categories based on potential and
7
inherent food safety risks. In addition, Standard 3 requires that regulatory
8
jurisdictions assign inspection frequency based on the risk categories to
9
focus program resources on food operations with the greatest food safety
Standard 3 of the Program Standards requires
10
risk.
With limited resources, creating a variable inspection frequency for
11
each category will allow inspection staff to effectively spend more time in
12
high risk establishments that pose the greatest potential risk of causing
13
foodborne illness.
14
Table 1 of this Annex provides an example of risk categories and
15
assignment of inspection frequency based on risk.
16
type of food served, food preparation processes conducted, and history of
17
compliance related to foodborne illness risk factors are used as the basis
18
of categorizing risk.
19
categories tailored to their specific program needs and resources and to
20
reassess the risk categories on an annual basis.
21
Regardless of the risk category initially assigned to food establishments,
22
regulatory jurisdictions sometimes consider whether the establishment has
23
implemented a voluntary food safety management system like HACCP, to
24
justify a decrease
25
are among many that regulatory jurisdictions sometimes use to justify an
26
increase in inspection frequency:
In this example, the
Each jurisdiction is encouraged to develop risk
in inspection frequency.
Likewise, the following factors
27
History of non-compliance with provisions related to foodborne
28
illness risk factors or critical items
29
Specialized processes conducted
30
Food preparation a day in advance of service
31
Large number of people served
Guam Food Code Annex 3 – Conducting Risk-based Inspections
5
1
History of foodborne illness and/or complaints
2
Highly susceptible population served.
3
Guam Food Code Annex 3 – Conducting Risk-based Inspections
6
1
Annex 3, Table 1. Risk Categorization of Food Establishments
2
3
RISK
4
CATEGORY
5
1
FREQUENCY
DESCRIPTION
Examples include most convenience store operations, hot dog
6
carts, and coffee shops. Establishments that serve or sell only
7
pre-packaged, nonpotentially hazardous foods (non
8
time/temperature control for safety (TCS) foods).
9
Establishments that prepare only nonpotentially hazardous
10
foods (nonTCS foods). Establishments that heat only
11
commercially processed, potentially hazardous foods (TCS
12
foods) for hot holding. No cooling of potentially hazardous
13
foods (TCS foods). Establishments that would otherwise be
14
grouped in Category 2 but have shown through historical
15
documentation to have achieved active managerial control
16
of foodborne illness risk factors.
17
2
serving a highly susceptible population, and quick service
19
operations. Limited menu. Most products are
20
prepared/cooked and served immediately. May involve hot
21
and cold holding of potentially hazardous foods (TCS foods)
22
after preparation or cooking. Complex preparation of
23
potentially hazardous foods (TCS foods) requiring cooking,
24
cooling, and reheating for hot holding is limited to only a few
25
potentially hazardous foods (TCS foods). Establishments that
26
would otherwise be grouped in Category 3 but have shown
27
through historical documentation to have achieved active
28
managerial control of foodborne illness risk factors. Newly
29
permitted establishments that would otherwise be grouped in
30
Category 1 until history of active managerial control of
31
foodborne illness risk factors is achieved and documented.
3
1
Examples may include retail food store operations, schools not
18
32
#/YR
2
An example is a full service restaurant. Extensive menu and
33
handling of raw ingredients. Complex preparation including
34
cooking, cooling, and reheating for hot holding involves many
35
potentially hazardous foods (TCS foods). Variety of processes
Guam Food Code Annex 3 – Conducting Risk-based Inspections
7
3
1
require hot and cold holding of potentially hazardous food
2
(TCS food). Establishments that would otherwise be grouped
3
in Category 4 but have shown through historical documentation
4
to have achieved active managerial control of foodborne illness
5
risk factors. Newly permitted establishments that would
6
otherwise be grouped in Category 2 until history of active
7
managerial control of foodborne illness risk factors is achieved
8
and documented.
9
4
Examples include preschools, hospitals, nursing homes, and
10
establishments conducting processing at retail. Includes
11
establishments serving a highly susceptible population or that
12
conduct specialized processes, e.g., smoking and curing;
13
reduced oxygen packaging for extended shelf-life.
14
15
Guam Food Code Annex 3 – Conducting Risk-based Inspections
8
4
1
B.
Have the Proper Equipment
2
In
3
provided with the proper equipment to assess the control of foodborne
4
illness risk factors within food establishments. See Program Standard 8 at
5
http://www.cfsan.fda.gov/~dms/ret-std8.html
6
equipment needed by inspectors.
7
be provided with the following essential equipment:
order
to
conduct
risk-based
8
Thermocouple
9
tested
with
inspections,
At
each inspector
for
must
recommendations
be
of
a minimum, each inspector should
the appropriate probes for the food being
10
Alcohol swabs or other suitable equipment for sanitizing probe
11
thermometers
12
Chemical test kits for different chemical sanitizer types
13
Heat-sensitive tape or maximum registering thermometer
14
Flashlight
15
Head cover, such as baseball cap, hair net, or equivalent.
16
Other equipment may be provided to inspectors on an “as needed” basis.
17
While it is desirable for each inspector to have the following equipment,
18
depending on the resources available to the agency, this equipment may
19
be shared in a central office as appropriate:
20
Pressure gauge for determining in-line pressure of hot water at
21
injection point of warewashing machine (15-25 psi)
22
Light meter
23
Measuring device for measuring distances
24
Time/temperature data logger
25
pH meter
26
Water activity meter
27
Camera
28
Computers with or without an electronic inspection system
29
Black light
30
Foodborne illness investigation kits
Guam Food Code Annex 3 – Conducting Risk-based Inspections
9
1
Sample collection kits
2
Cell phones.
3
C.
Provide Adequate Training
4
Standard 2 of the Program Standards explains that regulatory staff
5
shall have the knowledge, skills, and ability to adequately perform their
6
required duties.
7
expected to conduct risk-based inspections. Training includes a combination of
8
classroom training, in-field training, standardization, and continuing education.
9
For specific training recommendations refer to Program Standard 2 at
Inspectors need the proper training before they can be
10
http://www.cfsan.fda.gov/~dms/ret-std2.html.
11
Training
12
The first phase of staff training should provide an orientation to the
13
program with a review of program history, structure, and relationships to
14
other food-related
15
goals and objective.
16
components:
programs.
(1)
Classroom
Specific emphasis should be on the program’s
The basic training curriculum should include the following
17
Prevailing statutes, regulations, or ordinances
18
Public health principles
19
Communication skills
20
Epidemiology
21
Microbiology
22
HACCP.
23
FDA’s ORA-U (http://www.fda.gov/ora/training/) provides basic curriculum
24
components free of charge to regulators via the internet.
25
local, and tribal health departments to
26
resources instead of developing their own training courses.
27
inspectors to access training as needed. Distance learning allows government
28
agencies and industries to cost-effectively disseminate the most current
29
technical and regulatory information on an as-needed basis.
30
(2)
This allows state,
conserve their time and funding
Field Training and Experience
Guam Food Code Annex 3 – Conducting Risk-based Inspections
10
It also allows
1
The second phase of training should move the new inspector into the field
2
with a training officer. On-site training should focus on specific inspection
3
tasks such as interviewing, making observations, measuring conditions such
4
as temperatures and sanitizer strength, assessing the control operators
5
have over the foodborne illness risk factors, ensuring implementation of
6
Food
7
electronic database is used by the agency, training in its use should be
8
included in this phase.
9
The evaluation of food safety management systems based on HACCP principles
10
should be part of the field training experience. The trainee and the trainer should
11
review establishment menus, operations, recipes, and standard operating
12
procedures.
13
gathering
14
accurate charting of the food flows and determination of the Critical Control
15
Points (CCPs) and critical limits in an operation. This part of the training
16
should also include a familiarization with the compliance and enforcement
17
protocol in place in the jurisdiction including recommendation of voluntary
18
strategies to prevent risk factor occurrence.
19
Code
interventions,
completing
the
inspection
form.
If an
Inspectors should be able to demonstrate proficiency in
information
(3)
and
about
the
food
preparation processes,
including
Standardization
20
The third part of staff training should include standardization.
21
improves
22
regulations,
23
Standards
24
standardization
25
Procedures for Standardization and Certification of Retail Food Inspection/
26
Training Officers (http://www.cfsan.fda.gov/~ear/rfi-toc.html).
27
should be completed after the trainee completes classroom and field training.
28
(4)
uniformity
in
the
application
and
This process
interpretation of applicable
inspection methodology, and report writing.
recommend
process
that
staff
similar
to
conducting
the
one
The Program
inspections
described
undergo
in
the
a
FDA
Standardization
Continuing Education
29
The training process for inspection staff should be continuous.
30
of training should include a mechanism to ensure that learning is ongoing
31
and staff is kept abreast of food safety issues and the latest science.
Guam Food Code Annex 3 – Conducting Risk-based Inspections
11
The final phase
1
D.
Ensure Adequate Program Resources
2
As indicated in Standard 8 of the Program Standards, regulatory agencies
3
should have adequate funding, staff, and equipment necessary to support
4
a risk-based retail food safety program designed to reduce the occurrence
5
of
6
everything they can to secure funding and resources to support regulatory
7
food programs.
8
Standard 8 of the Program Standards also states that the program budget
9
should provide the necessary resources to develop and maintain a retail
10
food safety program that has a staffing level of one full-time equivalent
11
(FTE)
12
Inspections, for purposes of this calculation, include routine inspections, re-
13
inspections, complaint investigations, outbreak investigations, compliance
14
follow-up inspections, risk assessment reviews, process reviews, variance
15
process reviews, and other direct establishment contact time such as on-
16
site training.
foodborne
illness
devoted
to
risk
food
factors.
for
every
Program
management
280 - 320
inspections
should
do
performed.
17
18
4.
RISK-BASED INSPECTION METHODOLOGY
19
A.
Focus the Inspection
20
Conducting a risk-based inspection requires inspectors to focus their efforts
21
on evaluating the degree of active managerial control that operators have
22
over foodborne illness risk factors.
23
implementation of Food Code interventions also be verified during each
24
inspection. Inspectors need to spend the majority of their time observing
25
the behaviors, practices, and procedures that are likely to lead to out-of-
26
control foodborne illness risk factors and asking management and food
27
employees questions to supplement actual observations.
28
Retail and food service operators implement
29
food safety.
30
prevent, eliminate, or reduce food safety hazards.
31
determine the control measures that should be implemented to prevent the
In addition, it is essential that the
“control measures”
to
ensure
Control measures are actions or activities that are used to
Inspectors need to
Guam Food Code Annex 3 – Conducting Risk-based Inspections
12
1
occurrence of foodborne illness risk factors in each food preparation
2
process.
3
to each operation, it is important for inspectors to understand that the
4
food
5
initiated by a retail or food service operator represent a food safety
6
management system.
7
in order to gain information about the system already in place.
8
degree of active managerial control is determined, inspectors will be able
9
to
In order to determine the foodborne illness risk factors common
preparation
assist
processes
and
all
the
associated
control
measures
It will be necessary for inspectors to ask questions
operators
with
strengthening
their
existing
Once the
food
safety
10
management systems.
11
B.
12
Nonverbal communication is just as important as verbal communication in
13
relaying
14
operators.
15
demonstrate
16
information to the person in charge and food employees.
17
are ways that inspectors set the example during inspections:
Lead by Example
important
food
safety
principles
to
retail
and
food
service
By setting the example during inspections, inspectors not only
competency,
but
they
also
relay
important
food
safety
The following
18
Washing their hands when entering the food preparation area
19
at the beginning of the inspection and after engaging in any
20
activities that might contaminate their hands
21
Not working when they are suffering from symptoms such as
22
diarrhea, fever, vomiting, or jaundice or if they are diagnosed
23
with a disease transmittable by food
24
Being careful not to touch ready-to-eat (RTE) food with their
25
bare hands
26
Washing and sanitizing their thermocouple probe at the start
27
of the inspection and between foods
28
Using a proper hair restraint and practicing good personal
29
hygiene
Guam Food Code Annex 3 – Conducting Risk-based Inspections
13
1
Being careful not to contaminate clean and sanitized food
2
contact-surfaces
3
equipment.
with
unclean
hands
or
their
inspection
4
C.
Conduct Inspections at Variable Times
5
Inspectors should enter the food establishment during hours of operation
6
or at other reasonable times.
7
provide the permit holder or person in charge with a verbal or written
8
notice of the purpose of the inspection. Procedures outlined in the Food
9
Code and in the jurisdiction’s procedures should be followed if access to
Inspectors should show identification and
10
conduct an inspection is denied.
Refusal should be documented on the
11
inspection report and an administrative or judicial inspection order obtained.
12
In planning for inspections, inspectors should consider the importance of timing.
13
Several operational steps at retail such as receiving, preparation, and cooling
14
can be evaluated only during limited time periods. In order to properly evaluate
15
critical processes that occur outside of the normal 8 a.m. to 5 p.m. working
16
hours, an inspector should be allowed the flexibility to conduct inspections
17
early in the morning, late in the evening, and even on weekends.
18
D.
19
With the limited time allotted for inspections, inspectors must develop clear
20
priorities to make the most efficient use of their time in each food
21
establishment.
22
during the course of an inspection, critical behaviors, practices, and
23
procedures
24
observable during limited
25
process. For this reason, assessment of the active managerial control of
26
foodborne
27
reviewing basic sanitation issues.
28
To
29
completed early in the inspection:
Establish Inspection Priorities and Use Inspection Time Wisely
Although basic sanitation issues generally do not change
leading
illness
effectively
set
to
risk
foodborne
time
periods of
factors
priorities,
illness
should
the
risk
factors
may
be
the preparation or
generally
following
four
be
performed
activities
(1)
Establish an open dialogue with the person in charge
31
(2)
Review previous inspection records
14
cooling
before
should
30
Guam Food Code Annex 3 – Conducting Risk-based Inspections
only
be
1
(3)
Conduct a menu or food list review
2
(4)
Conduct a quick walk-though.
(1)
Establish an Open Dialogue with the Person in Charge
3
4
5
The tone of the inspection is often set during the first few minutes of the
6
inspection.
7
should be maintained.
8
staff translates into good relations which may be helpful in conveying the
9
goal of promoting public health.
Having an open dialogue with the person
10
in
of
11
opportunity to learn important information about the existing food safety
12
management system.
13
It is important to know both the strengths and weaknesses of the existing
14
food safety management system early in the inspection in order to focus
15
the
16
related to foodborne illness risk factors and Food Code interventions such
17
as the establishment’s employee health policy and consumer advisory
18
notice should be asked during all phases of the inspection.
19
important to ask enough questions to fully understand the system being
20
utilized in the food establishment.
21
whether the employees are adhering to the established no bare hand
22
contact and handwashing policies.
23
about important activities such as receiving, cooling, and preparation is
24
also important in relaying the importance of out-of-control foodborne illness
25
risk factors.
26
The person in charge should be encouraged to accompany inspectors during the
27
inspection. This may ultimately save time since violations can be pointed
28
out and corrected as they are observed.
29
violations
30
interventions is more apparent if they are pointed out during the inspection
31
rather than waiting until the end.
A professional but personable approach is the balance which
charge
during
all
Genuine interest in the food establishment and the
phases
inspection on weak areas.
related
to
the
inspection
gives
inspectors
an
Questions about practices and procedures
foodborne
This is especially true when evaluating
Asking the person in charge questions
illness
In addition, the importance of
risk
factors
and
Food Code
Violations should be marked on the
Guam Food Code Annex 3 – Conducting Risk-based Inspections
15
It is
1
inspection form even if immediate corrective actions are taken. Corrective
2
actions taken should also be recorded on the inspection form. Inspectors can
3
also use this time to share knowledge about critical processes.
4
communicating the public health rationale behind the regulations, inspectors
5
will leave the person in charge with a clear understanding for why active
6
managerial control of foodborne illness risk factors must be a top priority
7
in the day-to-day operation of the business.
8
Early in the inspection, inspectors should inquire about activities that are
9
presently occurring.
By
Processes that occur over time like cooling and
10
reheating also need to be assessed over time; thus, inspectors should ask
11
in the beginning of the inspection if any foods are currently being cooled
12
or reheated.
13
It is important for inspectors to allow the operator a chance to discuss
14
issues related to food safety. One-way communication in which inspectors
15
do all the talking is not conducive to a risk-based philosophy.
16
effective
17
maintain two-way communication in order to properly assess behaviors,
18
processes, and procedures that occur in the food establishment.
19
(2)
risk-based
inspection
is
dependent
on
inspectors’
ability
An
to
Review Previous Inspection Reports
20
In order to detect trends of out-of-control foodborne illness risk factors, it is
21
important for inspectors to review past inspection reports before conducting
22
an inspection.
This can be done in the office or on-site in the food
23
establishment.
This activity is especially important in jurisdictions where
24
inspectors rotate from one inspection to the next.
25
illness risk factor is out-of-control during more than one inspection, it is
26
strongly recommended that the operator develop an intervention strategy to
27
prevent its recurrence.
28
Annex.
29
Knowledge of what has been corrected from the last inspection also gives
30
inspectors an opportunity to provide positive feedback to the operator and
If the same foodborne
Intervention strategies are discussed later in this
Guam Food Code Annex 3 – Conducting Risk-based Inspections
16
1
allows inspectors to track corrected violations in accordance with their
2
jurisdiction’s policies and procedures.
(3)
3
Conduct a Menu / Food List Review
4
Menus, including all written and verbal lists of foods prepared and offered
5
in a food establishment, can be reviewed in a fairly simple manner. The
6
review can either be done simultaneously with a quick walk-through of the
7
operation
8
management. The menu/food list also does not need to be reviewed
9
during every inspection.
or
at
the beginning of the inspection as a discussion with
If a review was done during a recent inspection,
10
inspectors should inquire about new items, seasonal items, substitutions, or
11
changes in preparation since the last menu review was conducted.
12
A review of the menu/food list allows inspectors to begin to group food
13
items into one of three broad process categories (discussed in Annex 2 of
14
the Guam Food Code and later in this Annex).
15
products
16
control measures critical to each process. Conducting a review of the
17
menu/food list also allows inspectors to establish inspection priorities by
18
identifying:
Mentally grouping
by process assists inspectors in focusing the inspection on the
19
High-risk foods or high-risk food preparation processes
20
Operational steps requiring further inquiry such as receiving,
21
preparation, cooking, and cooling.
22
By
identifying
23
inspectors can focus the inspection on those foods or processes that are
24
more likely to cause foodborne illness if uncontrolled.
25
review might be the only time inspectors are made aware of specialized
26
processes
27
hazardous (time/temperature control for safety) food or high-risk seasonal
28
menu items such as “raw oysters on the half shell.”
29
shellstock and certain fish for raw consumption require documentation that
30
should be reviewed during the inspection. If Caesar salad or hollandaise
31
sauce is served, further inquiry is needed regarding the preparation of
such
high-risk foods or high-risk food preparation processes,
as
formulating
a
food so
The menu/food list
that it is
Guam Food Code Annex 3 – Conducting Risk-based Inspections
17
not
potentially
Foods such as
1
these items since they are sometimes prepared with raw or undercooked
2
eggs.
3
Several operational steps like receiving, preparation, cooking, and cooling
4
may not be inspected as vigorously in retail and food service inspections
5
due, in part, to the hours of the day in which these steps occur.
6
food establishment is inspected in the afternoon hours, for example,
7
receiving and food preparation might have already occurred.
8
evaluate the establishment’s active managerial control of foodborne illness
9
risk factors, it is imperative that inspectors ask enough questions to obtain
10
information about the operational steps that they cannot directly observe
11
during the current inspection.
(4)
12
If a
In order to
Conduct a Quick Walk-through
13
As
inspectors
discuss
the menu
or
food
list
and
establishes
open
14
communication with the person in charge, it is suggested that they
15
conduct a quick walk-through of the food establishment to observe what is
16
going on at that time.
17
important to observe several activities that might otherwise go unnoticed or
18
unobserved until later in the inspection, including:
Conducting a quick walk-through is especially
19
Receiving
20
Food preparation and handling
21
Cooking
22
Cooling
23
Reheating.
24
Speaking directly to the food service employees preparing the food is also
25
an excellent way to assess the effectiveness of the establishment’s food
26
safety training and standard operating procedures for critical processes
27
such as cooling. Noting that receiving or food preparation is occurring at
28
the beginning of the inspection allows inspectors an opportunity to take
29
advantage
30
inspectors to obtain a clear picture of the establishment's true practices.
31
Receiving
of
and
viewing
food
“real-life”
preparation
production
only
occur
processes
during
limited
Guam Food Code Annex 3 – Conducting Risk-based Inspections
18
and
will
times,
help
so
1
inspectors may want to stop and observe these operational steps while
2
they are happening.
3
Early
4
(time/temperature control for safety (TCS) foods) should be taken. For
5
example,
6
temperatures of last night’s stored leftovers. If inspecting in the afternoon,
7
inspectors should check the temperatures of foods prepared that morning
8
that are now cooling.
9
currently being cooked or reheated.
in
the
if
inspection,
inspecting
in
temperatures
the
of
morning,
potentially
inspectors
hazardous
should
foods
check
the
Also, inspectors should ask whether any foods are
10
E.
Determine Process Flows
11
Many retail and food service establishments have implemented effective
12
food safety management systems by establishing controls for the food
13
preparation methods and processes common to their operation. Control of
14
food preparation processes rather than individual food items is often called
15
the “process approach” to HACCP.
16
principles of HACCP can best be described as dividing the many food
17
items in an operation into food preparation processes then analyzing the
18
foodborne illness risk factors associated with each process.
19
managerial controls on specific operational steps in the flow of food,
20
foodborne illness can be prevented.
21
As presented in Annex 2 of the Guam Food Code, most food items
22
produced in a retail or food service establishment can be categorized into
23
one of three preparation processes based on the number of times the food
24
passes through the temperature danger zone between 41o F and 135o F.
25
In conducting risk-based inspections, it is necessary for an inspector to be
26
knowledgeable regarding how food is prepared in the operation. Knowing
27
how products are prepared in an establishment allows inspectors to focus
28
their inspections on the critical procedures and steps in the preparation of
29
those products.
30
F.
The process approach using the
By placing
Determine Foodborne Illness Risk Factors In Process Flows
Guam Food Code Annex 3 – Conducting Risk-based Inspections
19
1
Annex 2 of the Guam Food Code details the essential control measures
2
specific to each food preparation process, in addition to essential facility-
3
wide control measures. Inspectors should generally focus their inspections
4
on verifying that operators have implemented control measures to control
5
for foodborne illness risk factors common to the processes conducted in
6
each operation. There may be other foodborne illness risk factors unique
7
to specific operations; thus, inspectors should independently evaluate each
8
operation and food preparation process conducted.
9
G.
Assess
Active
Managerial
Control of Foodborne Illness Risk
Factors and Implementation of Food Code Interventions
10
11
Although some food establishments have formal HACCP plans, many do
12
not.
13
have active managerial control of foodborne illness risk factors. This may
14
be achieved through several means, such as training programs, manager
15
oversight, or standard operating procedures. For example, some food
16
establishments
17
production schedules, or employee job descriptions to achieve active
18
managerial control.
19
While a person in charge may require the maintenance of in-house written
20
records by employees to ensure that monitoring is being performed using
21
the correct method and at the proper frequency, foodborne illness risk
22
factors may be managed without the use of formal record keeping.
23
Monitoring, whether through direct observations or by taking appropriate
24
measurements, is by far the most important step in ensuring food safety.
25
If an operator is effectively monitoring all critical activities in the food
26
establishment and taking corrective actions when needed, safe food will
27
result.
28
required; therefore, records may not be in place for use during the
29
inspection. As a result, it will be necessary to use direct observations and
30
interviewing
Even without a HACCP system, every food establishment needs to
incorporate
control
measures
into
individual
recipes,
With a few exceptions, maintaining formal records at retail is not
to
determine
whether a food establishment is adequately
Guam Food Code Annex 3 – Conducting Risk-based Inspections
20
1
monitoring
2
management system.
3
This section provides a comprehensive discussion of how to assess the
4
active managerial control of each of the foodborne illness risk factors and
5
the implementation of each of the Food Code interventions.
6
of active managerial control involves more than determining compliance
7
with Food Code provisions.
8
managerial control, inspectors should observe whether the operator has
9
established the appropriate control measures and critical limits and whether
10
appropriate monitoring and corrective action procedures are in place and
11
followed.
12
employees
13
practices and procedures necessary to prevent foodborne illness. If during
14
the inspection inspectors observes that control measures are not being
15
implemented
16
corrective action must be taken.
17
(1)
foodborne illness risk factors in their existing food safety
Assessment
In assessing whether the operator has active
In addition, inspectors should assess whether managers and
are
knowledgeable
appropriately
of
food
safety
principles
and
critical
to control risk factor occurrence, immediate
Demonstration of Knowledge
18
It is the responsibility of the person in charge to ensure compliance with
19
the Code. Knowledge and application of Food Code provisions are vital to
20
preventing foodborne illness and injury. Data collected by FDA suggest
21
that having a certified food manager on-site has a positive effect on the
22
occurrence of certain foodborne illness risk factors in the industry.
23
In order to assess whether the person in charge demonstrates knowledge,
24
inspectors should verify that the person in charge has one or more of the
25
following:
26
A valid food protection manager certificate
27
No critical violations during the current inspection
28
Correct
29
presented in ¶ 2-102.11(C) of the Guam Food Code.
responses
to
food
safety
related
questions as
30
31
(2)
Assessing Safe Sources and Receiving Temperatures
Guam Food Code Annex 3 – Conducting Risk-based Inspections
21
1
The time and day of the inspection is important when assessing whether
2
foods are received from safe sources and in sound condition. Foods may
3
be received in the food establishment on set days.
4
questions to ascertain the day or days that deliveries are received and
5
also
6
Inspections can be scheduled at times when it is known that products will
7
be received by the food establishment. If food is being delivered during
8
the inspection, inspectors should:
the
receiving
procedures
in
place
by
the
Inspectors should ask
food
establishment.
Verify internal product temperatures
9
10
Examine package integrity upon delivery
11
Look for signs of temperature abuse (e.g., large ice crystals
12
in the packages of frozen products)
13
Examine delivery truck and products for potential for cross-
14
contamination
15
Observe the food establishment’s behaviors and practices as
16
they relate to the establishment’s control of contamination and
17
holding and cooling temperatures of received products
18
Review receiving logs and other documents, product labels,
19
and
20
regulated food processing plants (no foods prepared at home)
21
and at the proper temperature.
food
products
to ensure that foods are received from
22
When evaluating approved sources for shellfish, such as clams, oysters,
23
and mussels, inspectors should ask whether shellfish are served at any
24
time during the year. If so, inspectors should review the tags or labels to
25
verify that the supplier of the shellfish is certified and on the most current
26
Interstate
27
(http://www.cfsan.fda.gov/~ear/shellfis.html).
28
all
29
certification number, harvest waters and date, type and quantity of shellfish
30
and similar information for each dealer that handles the shellfish after the
Certified
required
information
Shellfish
is
provided
Shippers
Inspectors should note whether
on the tags or label (harvester’s
Guam Food Code Annex 3 – Conducting Risk-based Inspections
22
List
1
harvester).
Shellstock tags should also be retained for 90 days in
2
chronological order.
3
With regard to fish, inspectors should verify that fish are commercially
4
caught and harvested and received from reputable vendors.
5
being delivered during the inspection or if they were received just before
6
inspectors’ arrival, temperatures should be taken,
7
finfish such as tuna, mahi-mahi, bluefish, mackerel, and snapper. These
8
fish are subject to scombrotoxin formation if time/temperature abused.
9
Inspectors should verify freshness by conducting an organoleptic inspection
If fish are
especially if there are
10
of the gills, eyes, and bodies of the fish.
11
Inspector should verify that fish, except for certain species of tuna,
12
intended
13
required time and temperature parameters to destroy parasites by either
14
reviewing freezing records or verifying that a letter of guarantee from the
15
purveyor is kept on file. If freezing is conducted on-site, inspectors should
16
verify that the freezing records are maintained for at least 90 days beyond
17
the date of sale or service.
18
With regard to the service of game or wild mushrooms, inspectors should
19
ask if these products are served at any time during the year. If so,
20
inspectors should verify
21
reviewing invoices.
22
With regard to juice and milk products, inspectors should verify that fluid
23
milk and milk products are pasteurized and received at the proper
24
temperature. For packaged juice, inspectors should verify that the juice
25
was pasteurized or otherwise treated to achieve a 5-log reduction of the
26
most resistant microorganism.
27
During the inspection, inspectors should inquire as to the source of foods
28
that have been removed from their original containers.
29
during the inspection there is any doubt as to the source of certain
30
products, inspectors should ask for invoices or receipts to demonstrate
31
their source.
for
raw
or undercooked consumption have been frozen for the
that
they
are
from
an
approved
source
by
If at any time
Certain products, such as flat breads, waffles, pies, and
Guam Food Code Annex 3 – Conducting Risk-based Inspections
23
1
cakes may require special cooking equipment to prepare.
2
equipment is not on-site to prepare such products and the products are
3
not stored in original containers, then inspectors should inquire as to the
4
source of these products.
5
Food from unapproved, unsafe, or otherwise unverifiable sources should be
6
discarded
7
documentation is provided.
8
management and employees are aware of the risk of serving or selling
9
food from unapproved sources.
or
put
on
hold
or
under
embargo
If suitable
until
appropriate
In addition, inspectors should ensure that
Fish that are intended to be consumed
10
raw or undercooked and for which no freezing certification or equipment is
11
found on-site, can be used in menu items that will be fully cooked. If
12
cooking is not an option due to the menu items served, the fish should be
13
discarded.
(3)
14
Assessing
Contaminated
Equipment
and
Potential for
Cross-Contamination
15
16
This risk factor involves the proper storage and use of food products and
17
equipment to prevent cross-contamination.
18
storage of food-contact surfaces of equipment and utensils in a manner to
19
prevent
20
included in this risk factor.
21
As inspectors walk through the food establishment, they should examine
22
food
23
protection from contamination.
24
animal
25
storage,
26
returned to the same container that previously held uncooked product.
27
Cutting boards should be washed, rinsed, and sanitized between trimming
28
uncooked chicken and cooked steak.
29
In
30
temperatures such that foods requiring a higher cooking temperature, like
31
chicken, should be stored below or away from foods requiring a lower
transmission
storage
foods
and
addition,
of
areas
and
foodborne
for
animal
pathogens
storage,
or contamination is also
separation, segregation, and
Inspectors should look to see that raw
ready-to-eat
preparation.
raw
proper
The cleaning, sanitization, and
foods
For
foods
are
separated
during
example, cooked shrimp should not be
should
be
separated
Guam Food Code Annex 3 – Conducting Risk-based Inspections
24
receiving,
by
cooking
1
temperature, like pork and beef.
2
foods) are not being cooled, they should be covered or packaged while in
3
cold storage.
4
Following the flow of food as it is prepared in the food establishment may
5
alert
6
contamination has occurred between raw and ready-to-eat food, inspectors
7
should assess whether the food can be reconditioned.
8
depending on the affected food, it may be possible to reheat the food to
9
eliminate any hazards. If the food cannot be reconditioned, then the food
inspectors
to
opportunities
If potentially hazardous foods (TCS
for
cross-contamination.
When
In some cases,
10
should be discarded.
11
Inspectors should verify that exposed food such as chips, bread, and
12
dipping sauces are not re-served to the consumer.
13
operations are addressed in the Code with regard to the types of food
14
offered for consumer self-service, the protection of food on display, and
15
the required monitoring by employees of such operations.
16
A visual check of the food-contact surfaces of equipment and utensils
17
should
18
sanitized using the approved manner and frequency. Utensils that are
19
observed to have debris, grease, or other visible contamination should be
20
rewashed and re-sanitized.
21
Observations should be made to determine whether practices are in place
22
to eliminate the potential for contamination of utensils, equipment, and
23
single-service
24
consumers. When clean equipment and utensils are stored where they are
25
subject to environmental contamination such as near handwashing sinks or
26
prep sinks, inspectors should have the operator rearrange the equipment
27
in
28
circumstances,
29
equipment.
30
Inspectors should observe handwashing operations.
31
and fixtures are located where splash may contaminate food contact
a
be
made
to
items
manner
to
the
verify
by
that the utensils are maintained
environmental
contaminants,
prevent cross-contamination.
operator
Consumer self-service
clean
employees,
and
and
Depending on the
may need to rewash and re-sanitize the
If handwashing sinks
Guam Food Code Annex 3 – Conducting Risk-based Inspections
25
1
surfaces or food, then splash guards should be installed or food-contact
2
surfaces should be relocated to prevent cross-contamination.
3
Inspectors should pay particular attention to prep sinks, especially those
4
that are currently in use at the time of the inspection. Built-up grime is a
5
visible
6
appropriately before use. If there are designated vegetable or meat sinks,
7
inspectors should verify that the placement of sinks and food preparation
8
areas do not facilitate opportunities for cross-contamination from one to the
9
other.
10
With
11
inspectors should verify the compliance of any warewashing operations by
12
ensuring
13
surfaces conform to the requirements in the Food Code. Questions should
14
be asked to assess how utensils and cookware are washed, rinsed, and
15
sanitized in the food establishment.
16
procedure
17
cooking and baking equipment that is too large to fit in the dishmachine
18
or sinks. It is a good idea to have the person responsible for dishwashing
19
demonstrate the procedure that is followed in the food establishment by
20
setting up the sinks and watching the dishwashing procedure.
sign
regard
to
that
and
(4)
21
that
the
the
sink is not being washed, rinsed, and sanitized
cleaning and sanitization of food-contact surfaces,
cleaning
and
equipment,
sanitizing
inspectors
procedures
for
all
food-contact
When assessing the warewashing
should
pay particular attention to
Assessing Cooking Temperatures
22
Food cooking temperatures and times should be verified by inspectors
23
during each inspection.
24
cooking
25
establishment.
26
To
27
cooked.
28
such as lunch and dinner, as there may be a tendency for the operator
29
to rush the cooking of foods during these times.
30
Critical limits for cooking potentially hazardous foods (TCS foods) in the
31
Food Code include specifications that all parts of the food be heated to a
temperatures
assess
cooking,
Every effort should be made to assess the
of
a
variety
inspections
of
products served in the food
must occur at times when food is being
It is also important to conduct inspections during busy times,
Guam Food Code Annex 3 – Conducting Risk-based Inspections
26
1
certain temperature. For large roasts, temperature measurement should take
2
into account post-cooking heat rise which allows the temperature to reach
3
equilibrium throughout the food.
4
temperature must also be measured during inspections. For example, a
5
roast beef cooked at 54°C (130°F)
6
temperature for 112 minutes to ensure destruction of pathogens. Cooking
7
times and temperatures should be noted on the inspection report.
8
The correct temperature measuring device and technique are essential in
9
accurately determining the temperatures of potentially hazardous foods (TCS
The critical limit of time at the terminal
is required to be held at this
10
foods).
The geometric center or thickest part of a product is the points of
11
measurement of product temperature particularly when measuring critical
12
limits for cooking.
13
Inspectors
14
thermocouple or thermistor with a probe suitable for the product thickness.
15
A thin diameter probe should be used for temperature measurements of
16
hamburger patties and fish filets.
17
inspector may use a suitable, calibrated bimetal stem thermometer for
18
checking cooking temperatures of thick foods.
19
inappropriate for measuring internal cooking temperatures.
20
In order to better assess cooking during all phases of the inspection,
21
inspectors could enlist the help of cooperative food employees to notify
22
them of foods that have finished cooking.
23
continue with the inspection in other areas of the operation yet continue
24
to verify that proper cooking temperatures are being met.
25
Food
26
Inspections should verify that monitoring is occurring by involving the
27
person in charge in these activities during the regulatory inspection.
28
presence
29
assessed.
30
Comparisons should be made between inspectors’ calibrated temperature
31
measuring device and those used by the food establishment.
should
take
establishments
of
required
internal
should
temperatures
of
products using a
Alternately, although less desirable, an
routinely
thermometers
Infrared thermometers are
This allows inspectors to
monitor
and
their
cooking
proper
Guam Food Code Annex 3 – Conducting Risk-based Inspections
27
temperatures.
The
use should be
Notation of
1
deviations should be made on the inspection report. Inspectors should ask
2
food establishment personnel to demonstrate proper calibration of their
3
temperature measuring devices.
4
If required cooking temperatures are not met, inspectors should have the
5
operator continue cooking the food until the proper temperature is reached.
6
Additionally, inspectors should explain the public health significance of
7
inadequate cooking to management and food employees.
(5)
8
Assessing
Holding
Time
and
Temperatures and Date
Marking
9
10
Hot
and
cold
11
temperatures,
12
thoroughly checked with a thermocouple, thermistor, or other appropriate
13
temperature measuring device during each inspection.
14
temperature of potentially hazardous food (TCS food) during transport, e.g.,
15
hot holding carts being used to transport food to patient rooms in a
16
hospital, satellite kitchens, or off-site catering events.
17
effort should be made to assess every hot and cold holding unit in the
18
food establishment during a risk-based inspection.
19
Use of an infrared thermometer for verifying holding temperatures is not
20
consistent with Food Code requirements since verifying only the surface
21
temperature of the food may not alert inspectors to problems that exist
22
under the food’s surface.
23
cooling, in the case of cold-held foods, or improper reheating, in the case
24
of hot-held foods.
25
taking its temperature since it is important to know the temperature of the
26
food before it is agitated.
27
The
28
product
29
holding.
30
The hot holding critical limit may need additional measurements taken at
31
points farthest from the heat source, e.g., near the product surface for
of
holding
temperatures,
potentially
hazardous
as
well
as cooling time and
foods (TCS foods) should be
This includes the
As a rule, every
Such problems could stem from improper
In addition, inspectors should not stir a food before
geometric center of a product is usually the point of measurement of
temperature particularly when measuring the critical limit for cold
Guam Food Code Annex 3 – Conducting Risk-based Inspections
28
1
food held on a steam table.
Temperatures monitored between packages
2
of food, such as cartons of milk or packages of meat, may indicate the
3
need for further examination.
4
hazardous food (TCS food) itself, rather than the temperature between
5
packages, is necessary for regulatory citations. In large holding units and on
6
steam tables, it is necessary to take the temperatures of foods in various
7
locations to ensure that the equipment is working properly.
8
are noted in the product temperatures, it is important to take extra steps
9
to find out whether the problem is the result of equipment failure or
10
whether a breakdown in a process such as cooling or reheating is the
11
reason for the problem.
12
Corrective actions for foods found in violation should be required based on
13
the jurisdiction’s regulatory food code. If foods are to be discarded, forms
14
such as those used for stop sale or embargo may need to be completed
15
and signed by the person in charge in accordance with the jurisdiction’s
16
regulatory food code. In order to properly evaluate the degree of time and
17
temperature abuse and the proper disposition of the affected food, several
18
issues must be considered.
19
with observations made during the inspection, should provide inspectors
20
with enough information to make the appropriate recommendation for on-site
21
correction:
However, the temperature of a potentially
If deviations
Answers to these questions, in combination
22
Are there any written procedures in place for using time
23
alone as a public health control and, if so, are they being
24
followed properly?
25
What are the ingredients of the food and how was it made?
26
Is it likely that the food contains Clostridium perfringens,
27
Clostridium botulinum, or Bacillus cereus as hazards?
28
Has there been an opportunity for post-cook contamination
29
with raw animal foods or contaminated equipment?
30
If there has been an opportunity for post-cook contamination,
31
can the hazards of concern be eliminated by reheating?
Guam Food Code Annex 3 – Conducting Risk-based Inspections
29
1
Are
the
2
including frequent and effective handwashing?
3
Was
4
before being allowed out of temperature control?
5
What is the current temperature of the food when taken with a
6
probe thermometer?
7
How long has the food been out of temperature control (ask
8
both the manager and food employees)? Are the answers of
9
the food employees and the manager consistent with one
the
food employees practicing good personal hygiene
food reheated or cooked to the proper temperature
10
another?
11
Is it likely that food has cooled to its current temperature
12
after being out of temperature control for the alleged time?
13
Will the food be saved as leftovers?
14
How long before the food will be served?
15
Given what is known about the food, the food’s temperature,
16
the
17
temperature,
18
contains hazards that cannot be destroyed by reheating?
handling
of
is
it
the
food,
reasonably
and
the alleged time out of
likely
that
the
food already
19
Even if food can be reconditioned by reheating, steps should be taken by
20
the person in charge to ensure compliance in the future.
21
include repairing malfunctioning or inoperative equipment or implementing a
22
risk control plan (RCP) to modify preparation procedures or to institute a
23
procedure for monitoring holding temperatures of food.
24
If using time only or time-temperature combinations in lieu of temperature
25
for controlling the growth and toxin-formation of pathogenic bacteria, strict
26
controls must be in place and followed. Inspectors should verify that the
27
written procedures are on-site and followed in accordance with the Food
28
Code.
29
Date marking is the mechanism by which active managerial control of
30
time-temperature
31
monocytogenes in potentially hazardous (TCS), ready-to-eat foods during
combinations
can
prevent
the
growth
Guam Food Code Annex 3 – Conducting Risk-based Inspections
30
Examples
of
Listeria
1
cold storage. With exceptions, all ready-to-eat, potentially hazardous foods
2
(TCS foods) prepared on-site and held for more than 24 hours should be
3
date marked to indicate the day or date by which the foods need to be
4
served or discarded.
5
the system in place to control for L. monocytogenes meets the intent of
6
the Food Code.
7
discarded.
(6)
8
9
Inspectors should ask questions to ascertain whether
Food that should be date marked and is not should be
Assessing Reheating for Hot Holding
In order to assess a food establishment’s control of reheating for hot
10
holding, the time of day that the inspection occurs is a key factor.
11
effort
12
preparation. If inspections are conducted during pre-opening preparation or
13
other preparation periods, inspectors should ask questions regarding the
14
history
15
temperatures may have in fact been improperly reheated before being
16
placed into hot holding units or steam tables.
17
If items are found “reheating” on the steam table, further inquiry is needed
18
to assess whether the equipment in question is capable of reheating the
19
food to the proper temperature within the maximum time limit. Corrective
20
action for foods found out of compliance for reheating for hot holding
21
would depend on how long the food had been out of temperature and other
22
factors. In most cases, however, the food may be rapidly reheated and hot
23
held.
24
should
of
(7)
Every
be made to schedule an inspection during pre-opening
hot-held foods.
Foods in compliance for minimum hot holding
Assessing Cooling
25
Improper cooling remains a major contributor to bacterial foodborne illness.
26
Cooling temperatures and times need to be closely evaluated during every
27
inspection. In order to assess whether a food establishment has control over
28
cooling, the time of day that the inspection occurs is critical.
29
morning inspections allow an opportunity to verify that leftovers from the
30
night before were cooled properly or cooled using a proper cooling
31
method.
Early
Alternatively, afternoon inspections may allow an inspector to
Guam Food Code Annex 3 – Conducting Risk-based Inspections
31
1
verify cooling of products that may have been prepared that morning.
2
Because many food establishments prepare bulk products only on certain
3
days of the week, it is essential that inspectors become as familiar as
4
possible with each operation and schedule their inspections accordingly.
5
Due to the time parameters involved in cooling, inspectors should always
6
inquire at the beginning of the inspection whether there are any products
7
currently being cooled. This allows inspectors an opportunity to take initial
8
temperatures of the products and still have time to re-check temperatures
9
later in the inspection in order to verify that critical limits are being met.
10
Problems with cooling can often be discovered through inquiry alone.
11
Even when no cooling is taking place, inspectors should ask the food
12
employees and managers questions about the cooling procedures in place.
13
When
14
packed pans, shrouded rolling racks, or closed rolling cabinets should
15
warrant further temperature and time investigation.
16
buckets should be opened since they are commonly reused for food
17
storage and cooling.
18
The
19
measurement
20
critical limits for cooling. For foods that are being cooled, temperature
21
profiles throughout the product may show proper temperatures at outer
22
edges and hot spots at the core of the product. Inspectors can verify
23
cooling by first taking a temperature measurement in the geometric center
24
of the product, then at various points around the perimeter of the product.
25
Warmer temperatures in the center of the product, in combination with
26
cooler temperatures around the perimeter, indicate that a product is
27
cooling. Additional questions should be asked to ascertain the cooling time
28
parameters
29
employees
30
measurements taken, should form the basis for assessing compliance of
31
cooling during an inspection.
examining
geometric
holding
center
of
of
cold
product
the
and
food
of
units, bulk containers and buckets, tightly
a product is often chosen as the point of
temperature
in
Bulk containers and
question.
management,
in
particularly
when
Information
combination
gained
with
Guam Food Code Annex 3 – Conducting Risk-based Inspections
32
measuring
from
the
food
temperature
1
The following guidance may be used for determining the appropriate corrective
2
action for improper cooling. Cooked hot food may be reheated to 165 ºF for
3
15 seconds and the cooling process started again using a different cooling
4
method if the food is:
5
Above 70 ºF and two hours or less into the cooling process;
6
and
7
Above 41 ºF and six hours or less into the cooling process.
8
Cooked hot food should be discarded immediately if the food is:
Above 70 ºF and
9
more
10
process; or
11
Above 41 ºF and
12
process.
than two
hours
into
the cooling
more than six hours into the cooling
13
A different, more accelerated, cooling method may be used for prepared ready-
14
to-eat foods if the food is above 41 ºF and less than four hours into the cooling
15
process; however, such foods should be discarded if the food is above 41
16
ºF and more than four hours into the cooling process.
17
(8)
Assessing
Personal
Hygiene,
Hands
As
a
Vehicle
of
18
Contamination, and Proper Implementation of Employee
19
Health Policies
20
Special attention should be given to the potential for hands as a vehicle of
21
contamination.
22
contamination involves three elements:
An effective management system for prevention of hand
23
Employee health policy
24
Proper handwashing
25
No bare hand contact with ready-to-eat foods.
26
There are a wide range of communicable diseases and infections that can be
27
transmitted by an infected food employee.
28
associated with ill food employees begins with employing healthy people and
29
implementing a policy that excludes or restricts ill employees as specified in
30
Chapter 2 of the Food Code.
31
illnesses, or conditions that must be reported to the person in charge.
Proper management of the risks
Employees must be aware of the symptoms,
Guam Food Code Annex 3 – Conducting Risk-based Inspections
33
In
1
addition, the person in charge must be knowledgeable regarding the appropriate
2
action
3
reported.
4
With regard to the employee health policy, inspectors should ask a series
5
of open-ended questions to ascertain whether the employee health policy in
6
place complies with the Food Code. The following are example questions
7
that may be asked:
to
take
should
certain
symptoms,
illnesses,
or
conditions
be
8
What kind of policy do you have in place for handling sick
9
employees?
10
Is there a written policy? (Note: a written policy is not required in
11
the Food Code, but having a written policy may give an indication of
12
the formality of the policy being discussed.)
13
Describe
14
knowledgeable about their duties and responsibilities under the
15
employee health policy.
16
Are food employees asked if they are experiencing certain
17
symptoms or illnesses upon conditional offer of employment?
18
If so, what symptoms or illnesses are food employees asked
19
about? Is there a written record of this inquiry?
20
What are food employees instructed to do when they are
21
sick?
22
What conditions or symptoms are reported?
23
What may some indicators be of someone who is working
24
while ill?
25
When are employees restricted from working with exposed
26
food or food-contact surfaces?
27
working in the food establishment?
28

how
managers
and
food
employees
are
made
When are they excluded from
For employees that are sick and cannot come to work, what
29
policy is in place for allowing them to return and for notifying
30
the regulatory authority?
Guam Food Code Annex 3 – Conducting Risk-based Inspections
34
1
Special attention should be given to the potential for hands as a vehicle of
2
contamination. It must be a top priority during every inspection to ensure that
3
hands are washed using the proper procedure and at the appropriate times.
4
Data show that viruses can be tenacious even in the presence of good
5
handwashing. Inspectors should observe employee use of utensils and gloves
6
during the preparation and service of ready-to-eat foods and ingredients, such as
7
salads and sandwiches.
8
If ready-to-eat food is touched with bare hands, inspectors will need to address
9
several questions in order to make the appropriate on-site correction
10
recommendation. The answers to the following questions should provide enough
11
information to determine the likelihood of occurrence of hazards transmitted by
12
bare hands and should be the basis for making a recommendation for on-site
13
correction:
14
Does the facility have an employee health policy to identify, restrict,
15
and exclude ill employees?
16
Did the employees working with the food in question effectively
17
wash their hands and are handwashing facilities adequate?
18
Is there an approved, alternate procedure to no bare hand contact
19
in place and was it followed before the bare hand contact?
20
Has there been an opportunity for the employee’s hands to become
21
contaminated?
22
Inspectors should examine the location of handwashing sinks in relation to where
23
food is being prepared.
24
measurement as a guideline when considering the location and number of
25
handwashing sinks required in a food establishment during the plan review
26
process. While this information can be used to assist with the review
27
process, it should not be used as the sole basis for determining whether
28
there are an adequate number of handwashing sinks or whether the
29
handwashing sinks are conveniently located.
30
Special emphasis should be placed on spacing in and around fixed
31
equipment, the expected staffing, and the flow of food throughout a food
Many
jurisdictions
use
a
Guam Food Code Annex 3 – Conducting Risk-based Inspections
35
basic
distance
1
establishment. For instance, a kitchen may be 30 feet in length and 12 feet
2
wide. Although the size of the kitchen may dictate only one handwashing
3
sink using a basic distance measurement, if a prep table the length of the
4
line is placed between the line and the handwashing sink, the handwashing
5
sink may not be conveniently located. Likewise, one handwashing sink located
6
at the end of cook line is useless to employees working at the other end
7
if there is limited space for employees to go around one another during busy
8
periods.
9
(9)
Assessing Compliance with Approved Procedures
10
When conducting certain specialized processes, variances and HACCP plans
11
are required by the Code. This is because such processes carry a considerable
12
risk if not conducted under strict controls. For food establishments conducting
13
specialized processes, each inspection should involve a review of the written
14
variance, if applicable, and the implementation of the HACCP plan to ensure that
15
food safety hazards are being consistently controlled.
16
(10)
Assessing Special Requirements Related to Highly
Susceptible Populations (HSP)
17
18
Food establishments that serve highly susceptible populations (HSP) must
19
adhere to additional requirements as specified under Part 3-8 of the Code. Every
20
effort should be made to inspect such facilities during preparation, service, or
21
other applicable times to assess these additional requirements as well as those
22
in other sections of the Food Code.
23
Because those persons who are very young, elderly, or who live in a facility that
24
provides custodial care are extremely vulnerable to foodborne illness because of
25
age or health status, it is important that risk factors be controlled on-site in a
26
timely manner. Inspections of HSP facilities should be conducted by inspectors
27
knowledgeable in the control of foodborne illness risk factors who take extra care
28
to assure that the most vulnerable segment of the population are not at risk.
29
30
(11)
Assessing Labeling, Storage, and Use of Poisonous and
Toxic Chemicals
Guam Food Code Annex 3 – Conducting Risk-based Inspections
36
1
During each inspection, the proper labeling, storage, and use of poisonous and
2
toxic chemicals should be verified. Containers of poisonous or toxic materials
3
and personal care items shall bear a legible manufacturer's label.
4
containers used for storing poisonous or toxic materials such as cleaners and
5
sanitizers taken from bulk supplies should be clearly and individually identified
6
with the common name of the material. Only chemicals that are necessary to the
7
operation and maintenance of a food establishment, such as for the cleaning and
8
sanitizing of equipment and utensils and the control of insects and rodents,
9
should be in the food establishment. Medicines necessary for the health of
10
employees may be allowed in a food establishment, but they should be labeled
11
and stored to prevent contamination of food and food-contact surfaces.
12
Inspectors should verify that solutions containing poisonous and toxic
13
chemicals, like mop water, are discarded in an appropriate service sink to
14
prevent contamination of food and food-contact surfaces. In addition,
15
inspectors should check delivery trucks to verify that food is protected
16
from chemical contamination during shipment. Any food that has been cross-
17
contaminated with poisonous or toxic chemicals should be discarded or
18
rejected immediately.
(12)
19
Working
Assessing Compliance with Consumer Advisory
20
Inspectors should ascertain whether animal foods such as beef, eggs, fish,
21
lamb, milk, pork, poultry, or shellfish are served or sold raw, undercooked, or
22
without otherwise being processed to eliminate pathogens, either in ready-to-eat
23
form or as an ingredient in another ready-to-eat food. Inspectors should review
24
the menu or food list to verify that a consumer advisory with a disclosure and
25
reminder is present as specified under § 3-603.11 of the Food Code.
26
In
27
whether raw or
28
seasonally. It is useful to know foods that are often served in this manner
29
such as oysters-on-the half shell, hollandaise sauce, béarnaise sauce, eggnog,
30
salad dressings, hamburgers to order, or sunny-side-up eggs.
31
H.
addition to reviewing the menu or food list, inspectors should ask
undercooked
foods
are
served
or
sold
Evaluating Basic Sanitation and Facilities (Good Retail
Guam Food Code Annex 3 – Conducting Risk-based Inspections
37
routinely or
Practices)
1
An important part of a risk-based, routine inspection is to review how the food
2
establishment actively monitors the active managerial control of foodborne illness
3
risk factors and interventions; however, overall sanitation should not be
4
overlooked. Systems to control basic operational and sanitation conditions within
5
a food establishment, referred to as Good Retail Practices (GRPs), are the
6
foundation of a successful food safety management system. GRPs found to be
7
out-of-compliance may give rise to conditions that may lead to foodborne illness,
8
e.g., sewage backing up in the kitchen. Just as monitoring is required by the
9
food establishment to ensure that foodborne illness risk factors are controlled
10
and interventions are in place, monitoring of basic sanitation conditions in the
11
food establishment allows the operator an excellent opportunity to detect
12
weaknesses and initiate actions for improvement.
13
sanitation programs must be in place to:
Basic operational and
14
Protect products from contamination by biological, chemical, and
15
physical food safety hazards
16
Control bacterial growth that can result from temperature abuse
17
during storage
18
Maintain equipment, especially equipment used to maintain product
19
temperatures.
20
Examples of concerns addressed by the basic operation and sanitation programs
21
mentioned above include the following:
22
Pest control
23
Food protection (non-critical)
24
Equipment maintenance
25
Water
26
Plumbing
27
Toilet facilities
28
Sewage
29
Garbage and refuse disposal
30
Physical facilities.
31
Guam Food Code Annex 3 – Conducting Risk-based Inspections
38
1
5.
ACHIEVING ON-SITE AND LONG-TERM COMPLIANCE
2
A.
Developing an Effective Compliance and Enforcement
3
Compliance and enforcement are essential elements of a regulatory program and
4
encompass all voluntary and regulatory enforcement actions taken to achieve
5
compliance with regulations.
6
explain the need of regulatory jurisdictions to establish a compliance and
7
enforcement protocol that results in credible follow-up for each violation noted
8
during an inspection, especially violations related to foodborne illness risk factors
9
and Food Code interventions. Lack of follow-up on the part of the regulatory
10
agency signals to the operator that the critical violations noted were not
11
important.
12
The resolution of out-of-compliance foodborne illness risk factors and Food Code
13
interventions must be documented in each food establishment record.
14
desired outcome of Standard 6 is an effective compliance and enforcement
15
program that is implemented consistently to achieve compliance with regulatory
16
requirements.
17
Compliance and enforcement options may vary depending on state and local
18
law. It is essential that regulatory jurisdictions develop a written compliance and
19
enforcement protocol that details the order in which both voluntary corrections
20
may be taken on the part of the operator and involuntary enforcement actions are
21
to be taken on the part of the regulatory authority.
22
actions include, but are not limited to, such activities as warning letters, re-
23
inspections, citations, administrative fines, permit suspensions, and hearings.
24
Food establishment with a history of noncompliance at a level predetermined by
25
the jurisdiction or with the number of foodborne illness risk factors and
26
interventions violated warranting a regulatory action, signals the need either a
27
strong regulatory response or an alternate approach to compliance to protect
28
public health, e.g., active managerial control, behavioral change.
29
Voluntary corrections taken on the part of the operator include, but are not limited
30
to, such activities as on-site corrections at the time of inspection, voluntary
31
destruction, risk control plans, and remedial training.
Protocol
Standards 3 and 6 of the Program Standards
Involuntary enforcement
Obtaining voluntary
Guam Food Code Annex 3 – Conducting Risk-based Inspections
39
The
1
corrections by the operator can be very effective in achieving long-term
2
compliance.
3
Regulator’s Manual as “intervention strategies.” Intervention strategies can be
4
divided into two groups:
Voluntary corrections by the operator are referred to in FDA’s
5
Those designed to achieve immediate on-site correction
6
Those designed to achieve long-term compliance.
7
Successful intervention strategies for out-of-control foodborne illness risk factors
8
can be tailored to each operation’s resources and needs.
9
inspectors to work with the operator to identify weaknesses in the existing food
10
safety management system and consulting with the operator to strengthen any
11
weak areas noted.
12
B.
13
On-site corrections are intended to achieve immediate corrective action of
14
out-of-control foodborne illness risk factors posing an immediate, serious
15
danger to the consumer during the inspection.
16
“operational” rather than structural and can be addressed by management
17
at the time of the inspection.
18
It is essential to consumer protection and to regulatory credibility for on-
19
site correction to be obtained for any out-of-control foodborne illness risk
20
factors
21
establishment.
22
violation to management. Failure to require on-site correction when an out-of-
23
control risk factor has been identified implies that the risk factor has little
24
importance to food safety.
25
When recommending on-site correction, effective communication regarding out-
26
of-control foodborne illness risk factors is essential and can be accomplished
27
best by:
This will require
On-site Correction
before
completing
the
inspection
Usually these violations are
and
leaving
the
food
Obtaining on-site correction conveys the seriousness of the
28
Discussing food safety concerns in words that can be easily
29
understood by the person in charge and employees
30
Conveying the seriousness of the out-of-control foodborne illness
31
risk factors in terms of increased risk of illness or injury.
Guam Food Code Annex 3 – Conducting Risk-based Inspections
40
1
During the discussion of inspection findings with the person in charge, inspectors
2
should keep the discussion focused on correction of violations that present an
3
immediate danger to the consumer. Discussion of less serious code violations
4
should be deferred until out-of-control foodborne illness risk factors are
5
discussed and on-site correction is obtained.
6
In most cases, selecting the most appropriate on-site correction when out-of-
7
control foodborne illness risk factors are observed will be straightforward;
8
however, in instances such as improper cooling, the appropriate corrective action
9
may be more complicated. Since determining on-site correction depends on a
10
number of factors, an inspector may need to conduct a hazard analysis of the
11
food in order to determine the appropriate course of action to take.
12
C.
13
While on-site correction of out-of-control foodborne illness risk factors is essential
14
to consumer protection, achieving long-term compliance and behavior change is
15
equally
16
compliance will help in achieving a desirable change of behavior. For example,
17
in jurisdictions using a
18
violations are marked, it is often taken for granted that if there are no
19
violations marked, the foodborne illness risk factors are being controlled.
20
This is not necessarily true since the observation of code violations is
21
subject to many variables such as the time of day, day of the week, or
22
duration of the inspection. An inspection system that records only observed
23
violations rather than the actual status of all foodborne illness risk factors,
24
such as whether the risk factor was in compliance, not observed, or not
25
applicable to the operation, may be unable to detect some foodborne
26
illness risk factors that are continually or cyclically out of control.
27
Another misconception is that training alone will result in foodborne illness risk
28
factors being controlled. While training may help, there is no guarantee that
29
knowledge acquired will equate to knowledge applied in the workplace. In
30
order
31
reinforced and the behavior must be repeated for a period of time
Intervention Strategies for Achieving Long-term Compliance
important.
for
Overcoming
knowledge
several
misconceptions
about
long-term
44-item inspection report in which only observed
to
translate
into
changed
behavior,
Guam Food Code Annex 3 – Conducting Risk-based Inspections
41
it
must be
1
sufficient
for
2
assumption is that regulatory enforcement actions such as citations or
3
administrative hearings or on-site corrections alone will automatically result in
4
future management control. Unfortunately, there is no assurance that any of
5
these actions will result in the long-term control of foodborne illness risk
6
factors.
7
Long-term compliance may best be achieved through voluntary actions by
8
the
9
management system is needed, there is a better chance that long-term
operator.
the
behavior
to become
an ingrained pattern.
Another
If an operator supports the concept that a food safety
10
compliance
11
ensure long-term active managerial control of foodborne illness risk factors.
12
(1)
will be achieved.
The following are ways operators can better
Change Equipment and Layout
13
Critical limits are difficult to achieve when equipment does not work properly.
14
Proper calibration of equipment is vital to achieving food safety.
15
calibration
16
replaced. In addition to equipment malfunctioning, poor equipment layout can
17
present opportunities for cross contamination and must be considered.
18
example:
is
unsuccessful
or
is
not
feasible,
equipment
should
be
For
19
Hamburgers with uniform thickness
20
reaching a safe cooking temperature in a given time.
21
examination, it is determined that the grill is distributing heat
22
unevenly. A new element is installed to correct the problem.
23
Splash from a nearby handwashing sink is seen on a prep table. A
24
splash guard is installed to prevent cross contamination from the
25
handwashing sink to the prep table.
26
(2)
and
When
weight are not all
Upon
Establish Buyer Specifications
27
Written specifications for the goods and services purchased by a food
28
establishment prevent many problems. For example:
29
Fish posing a parasite hazard and intended for raw consumption
30
have not been frozen for the specified time and temperature
31
and no freezing equipment is on-site at the food establishment.
Guam Food Code Annex 3 – Conducting Risk-based Inspections
42
1
Buyer specifications are established to place the responsibility for
2
freezing the fish on the supplier.
3
Lobster tails, hamburgers, or other products cooked with a set
4
time parameter on a conveyor are not reaching the proper
5
temperature in the specified time because they are larger
6
than the size for which the conveyor is calibrated. Buyer
7
specifications are established to restrict the size of products
8
received from the supplier.
9
(3)
Develop and Implement Recipe/Process Instructions
10
Simple control measures integrated into recipes and processes can improve
11
management control over foodborne illness risk factors. For example:
12
Process instructions that specify using color-coded cutting boards
13
for separating raw animal foods from ready-to-eat products are
14
developed to control the potential for cross contamination.
15
Pasteurized eggs are substituted in recipes that call for raw or
16
undercooked eggs to reduce the risk of foodborne illness.
17
Commercially precooked chicken is used in recipes calling for
18
cooked chicken such as chicken salad to reduce the risk of
19
contaminating food-contact surfaces and ready-to-eat food with
20
raw chicken.
21
Pasta is chilled in an ice bath immediately after cooking and
22
before apportioning into single servings. This is specified in
23
the procedures for cooking spaghetti.
Guam Food Code Annex 3 – Conducting Risk-based Inspections
43
(4)
1
Establish First-In-First-Out (FIFO) Procedures
2
Product rotation is important for both quality and safety reasons. “First-In-First-
3
Out” (FIFO) means
4
storage should be the first one sold or used.
5
required
6
refrigerated, ready-to-eat, potentially hazardous foods (TCS foods). The FIFO
7
concept limits the potential for pathogen growth, encourages product rotation,
8
and documents compliance with time/temperature requirements.
(5)
9
by
that
the first batch of product prepared and placed in
Date marking foods as
the Food Code facilitates the use of a FIFO procedure in
Develop and Implement Standard Operating Procedures
(SOPs)
10
11
Following
standardized, written
procedures for performing various tasks
12
ensures that quality, efficiency, and safety criteria are met each time the
13
task is performed.
14
contains some common management areas that can be controlled with
15
SOPs:
Although every operation is unique, the following list
16
Personnel (disease control, cleanliness, training)
17
Facility maintenance
18
Sanitary conditions (general cleaning schedule, chemical storage,
19
pest control, sanitization of food-contact surfaces)
20
Sanitary facilities (approved water supply and testing, if applicable,
21
scheduled in-house inspection of plumbing, sewage disposal,
22
handwashing and toilet facilities, trash removal)
23
Equipment and utensil maintenance.
24
SOPs can also be developed to detail procedures for
25
controlling foodborne illness risk factors:
26
Procedures are implemented for measuring temperatures at a
27
given frequency and for taking appropriate corrective actions to
28
prevent hazards associated inadequate cooking.
29
Adequate handwashing is achieved by following written procedures
30
that dictate frequency, proper technique, and monitoring.
31
(6)
Develop and Implement Risk Control Plans (RCPs)
Guam Food Code Annex 3 – Conducting Risk-based Inspections
44
1
An RCP is a concisely written management plan developed by the retail or
2
food
3
management system for controlling specific out-of-control foodborne illness risk
4
factors. An RCP is intended to be a voluntary strategy that inspectors and
5
the
6
specific out-of-control foodborne illness risk factors. For example, if food is
7
improperly cooled in the establishment, a system of monitoring and record
8
keeping
9
established to adequately cool the food in the future. An RCP should require
10
that the basic control systems in the plan be implemented for a designated
11
period of time (e.g., 60 – 90 days) and allow inspector oversight. The longer
12
the plan is implemented, the more likely it is that the new controls will
13
become “habits” that continue to be used in the food establishment after
14
inspector oversight ends.
15
An RCP should stress simple control measures that can be integrated into the
16
daily routine. It should be brief, no more than one page for each risk
17
factor, and address the following points in very specific terms:
service
person
operator
in
with
input
from
inspectors
that describes a
charge jointly develop to promote long-term compliance for
outlined
in
an
RCP
can
ensure
that
new
procedures are
18
What is the risk factor to be controlled?
19
How is the risk factor controlled?
20
Who is responsible for the control?
21
What monitoring and record keeping is required?
22
Who is responsible for monitoring and completing records?
23
What corrective actions should be taken when deviations are
24
noted?
25
How long is the plan to continue?
26
How are the results of the RCP communicated to inspectors?
27
By implementing an RCP, the retail or food service operator will have the
28
opportunity to determine the appropriate corrective action for the identified
29
problem and design an implementation strategy to best suit the establishment
30
and operation.
31
establishment, the operator takes complete ownership of the plan and is
Since the RCP is tailored to meet the needs of the food
Guam Food Code Annex 3 – Conducting Risk-based Inspections
45
1
ultimately responsible for its development and implementation.
The role of
2
inspectors is to consult with the operator by suggesting ways that the risk
3
factor(s) might be controlled.
4
By creating an RCP, the operator realizes that a problem exists in the
5
established
6
correction plan rather than merely acknowledging a single violation. Follow up
7
by telephone or
8
interested in seeing the plan succeed.
9
opportunity to answer any questions and offer feedback to the operator to
food safety management system and commits to a specific
in
person indicates to the operator that inspectors are
gives
inspectors an
make the RCP more useful.
11
template that can be used by regulatory jurisdictions, is found in FDA’s
12
Regulator’s Manual: http://www.cfsan.fda.gov/~dms/hret3toc.html.
(7)
example
also
10
13
An
This
of an RCP, along with a blank
Develop and Implement Comprehensive Voluntary Food Safety
Management Systems based on HACCP
14
Principles
15
The Food Code only requires HACCP plans for a few specialized processes;
16
however, the development of voluntary HACCP plans is always encouraged.
17
FDA Operator’s Manual, “Managing Food Safety: A Manual for the Voluntary
18
Use of HACCP Principles for Operators of Food Service and Retail
19
Establishments” is written to aid food establishment managers in the
20
development of food
21
principles.
22
appropriate regulatory authority or other food safety professional, can use
23
this document to establish an effective food safety management system to
24
control for all foodborne illness risk factors. This document is available from
25
FDA through the following website: http://www.cfsan.fda.gov/~dms/hret2toc.html.
safety
A retail or food
management
service
systems
operator,
in
based on HACCP
consultation
with
an
26
27
6.
INSPECTION FORM AND SCORING
28
A.
The Inspection Form
29
The inspection form is the official document utilized by a regulatory
30
agency for documentation of compliance of the food establishment with
31
regulatory requirements. The goal of the inspection form is to clearly,
Guam Food Code Annex 3 – Conducting Risk-based Inspections
46
1
concisely, and fairly present the compliance status of the food establishment
2
and to convey compliance information to the permit holder or person in charge
3
at the conclusion of the inspection.
4
The inspection report should be kept in the food establishment's files for
5
subsequent
6
Individual inspection reports are to be made available for public review in
7
accordance with Freedom of Information criteria.
8
Annex 7 of the Model Food Code provides an inspection form that may be
9
completed for routine, follow-up, and compliance inspections. This inspection
10
form meets requirements established in Standards 3 and 6 of the Program
11
Standards.
12
B.
13
If a violation exists during an inspection, it should always be marked on the
14
inspection report, even if corrected on site. Violations existing at the time
15
of the inspection probably would have
16
inspection. Slight violations, such as one dirty utensil among hundreds of
17
clean utensils, do not indicate that the food establishment is significantly
18
deviating from the Code requirements; therefore, discretion in marking is
19
required.
20
It is very important to investigate the root causes of violations and mark them
21
appropriately. Without taking this extra step, inspectors will merely point out
22
violations and will not identify weaknesses in the management system in
23
place.
24
violations is expected, inspectors must identify the causes.
25
C.
26
Regulatory agencies may use scoring methods to rate food establishments.
27
Depending on the system
28
indication of how well a food establishment is complying with the food
29
safety rules of the regulatory agency.
30
Some agencies use a system of compliance tools as provided in Chapter 8
31
and Annex 1 of the Model Food Code to protect public health. The inspection
compliance actions and review before the next inspection.
Debiting Methodology
If long-term control of
the
persisted
behaviors
or
if
it
were not for the
practices leading to the
Scoring
used,
establishment
scoring may provide an
Guam Food Code Annex 3 – Conducting Risk-based Inspections
47
1
score may serve as the basis for triggering follow-up inspections or other
2
forms of regulatory sanctions when they fall too far from the accepted
3
levels. In addition, scoring may provide a mechanism for consumers to make
4
informed choices regarding where they want to eat.
5
Use of scoring systems also has negative consequences. For example, it
6
is possible for a food establishment to receive a high numerical or letter
7
score while exhibiting some very serious deficiencies.
8
drawback, some jurisdictions forego scoring systems in favor of demerits or
9
debit systems without assigning a final score.
In recognition of this
This focuses attention on the
10
items needing correction. Compliance and enforcement decisions can still be
11
based on the increasing levels of identified deficiencies. Whatever method or
12
system of establishment rating is used, policies regarding follow-up and
13
enforcement actions should be established in writing, linked to the rating
14
system, and administered consistently.
15
7.
16
The closing conference should include a detailed discussion of the food
17
establishment's plans for correcting violations found during the inspection. The
18
evidence collected or observed during the inspection and the alternatives
19
available for compliance should be emphasized.
20
during the inspection should be acknowledged on the inspection report and
21
in the closing conference.
22
The compliance plan should address changes in procedures that will prevent
23
the recurrence of noted violations. The food establishment's compliance plans
24
should be formally documented on the inspection report form. Follow-up
25
letters may be necessary to elicit fulfillment of these agreements. It is
26
important to stress to the operator that long-term correction of violations
27
related to foodborne illness risk factors and Food Code interventions is far
28
more important than corrections of non-critical items.
CLOSING CONFERENCE
On-site corrections made
29
30
8.
SUMMARY
Guam Food Code Annex 3 – Conducting Risk-based Inspections
48
1
Although a retail and food service
2
establishing a food safety management system for controlling foodborne illness
3
risk factors, inspectors have a vital, multi-faceted role in consumer protection. It
4
is
5
equipment, time, and resources to adequately perform their jobs.
6
The primary role of inspectors is to ensure that the operator has effective
7
control of foodborne illness risk factors. Once inspectors have established a
8
dialogue
9
menu/food list review, and established a dialogue with the person in charge,
10
inspectors will have enough information to mentally place menu items into
11
one
12
assessing the operator’s active managerial control of foodborne illness risk
13
factors associated with each process.
14
Once out-of-control foodborne illness risk factors are identified, the role of
15
inspectors shifts to assisting the operator with strengthening the existing food
16
safety management system through intervention strategies designed to achieve
17
immediate and long-term compliance. With inspector’s assistance, a retail and
18
food service operator can achieve long-term behavioral change resulting in a
19
reduction
20
protection.
essential
of
with
the
in
that
the
three
risk
inspectors
person
process
factor
operator
are
in
has
provided
charge
flows.
occurrence
and
the
with
an
proper
employees,
The inspection
and
the
responsibility
increase
Guam Food Code Annex 3 – Conducting Risk-based Inspections
49
training,
conducted
can then
for
a
focus on
in public health
1
Guam Annex
2
4
Food Processing Criteria
3
1.
INTRODUCTION
4
2.
REDUCED OXYGEN PACKAGING
5
3.
SMOKING AND CURING
7
1.
INTRODUCTION
8
From its inception, the retail segment of the food industry has prepared foods in
9
consumer-sized portions, using commercially available equipment for cutting,
10
grinding, slicing, cooking, and refrigeration, and applying herbs and spices readily
11
available to consumers at their local grocery.
12
Over the past score of years, retail segment operators have expanded into food
13
manufacturing/processing-type operations, often using sophisticated new
14
technologies and equipment that are sometimes microprocessor-controlled. Many
15
now desire to alter the atmospheres within food packages, or apply federally
16
regulated chemical food additives as a method of food preservation.
17
processing operations now being conducted or proposed include cook-chill; vacuum
18
packaging; sous vide; smoking and curing; brewing, processing, and bottling
19
alcoholic beverages, carbonated beverages, or drinking water; and custom
20
processing of animals.
21
The Guam Food Code specifies that a HACCP plan acceptable to the regulatory
22
authority be the basis for approving food manufacturing/processing operations at
23
retail. The HACCP plans are to be provided and accepted in two ways as follows.
24
(A)
25
Section 3-502.12 of the Guam Food Code provides the criteria that are to be met in
26
the HACCP plans of those operators who are conducting reduced oxygen
27
packaging (ROP) operations. Unless prior approval of the HACCP plan is required
28
by the regulatory authority, the HACCP plan covering this operation along with the
29
related records documenting monitoring and corrective actions need only be
6
Food
Reduced Oxygen Packaging
Guam Food Code Annex 4 – Food Processing Criteria
1
1
available and acceptable to the regulatory authority at the time of inspection.
2
(B)
3
Except for ROP as discussed in (A) above, the Food Code specifies under §§ 3-
4
502.11, 8-103.10, 8-103.11, and 8-201.13 that the food establishment operator
5
must
6
manufacturing/processing operations based on the prior approval of a HACCP plan.
7
The purpose of this Annex is to provide processing criteria for different types of
8
food manufacturing/processing operations for use by those preparing and reviewing
9
HACCP plans and proposals. Criteria for additional processes will be provided as
10
Other Food Manufacturing/Processing Operations
obtain
a
variance
from
the
regulatory
authority
for
all
food
they are developed, reviewed, and accepted.
11
12
2.
REDUCED OXYGEN PACKAGING
13
(A)
Introduction
14
ROP which provides an environment that contains little or no oxygen, offers
15
unique advantages and opportunities for the food industry but also raises many
16
microbiological concerns. Products packaged using ROP may be produced safely
17
if proper controls are in effect. Producing and distributing these products with a
18
HACCP approach offer an effective, rational, and systematic method for the
19
assurance of food safety. The purpose of this Annex is to provide guidelines for
20
effective food safety controls for retail food establishments covering the receipt,
21
processing, packaging, holding, displaying, and labeling of food in reduced oxygen
22
packages.
23
(B)
24
The term ROP is defined as any packaging procedure that results in a reduced
25
oxygen level in a sealed package. The term is often used because it is an
26
inclusive term and can include other packaging options such as:
27
Definitions
(1)
Cook-chill is a process that uses a plastic bag filled with hot
28
cooked food from which air has been expelled and which is
29
closed with a plastic or metal crimp.
30
(2)
Controlled Atmosphere Packaging (CAP) is an active system which
Guam Food Code Annex 4 – Food Processing Criteria
2
1
continuously maintains the desired atmosphere within a package
2
throughout the shelf-life of a product by the use of agents to bind or
3
scavenge oxygen or a sachet containing compounds to emit a gas.
4
CAP is defined as packaging of a product in a modified atmosphere
5
followed by maintaining subsequent control of that atmosphere.
6
(3)
Modified Atmosphere Packaging (MAP) is a process that employs a
7
gas flushing and sealing process or reduction of oxygen through
8
respiration of vegetables or microbial action. MAP is defined as
9
packaging of a product in an atmosphere which has had a one-time
10
modification of gaseous composition so that it is different from that of
11
air, which normally contains 78.08% nitrogen, 20.96% oxygen, 0.03%
12
carbon dioxide.
13
(4)
Sous Vide is a specialized process of ROP for partially cooked
14
ingredients alone or combined with raw foods that require
15
refrigeration or frozen storage until the package is thoroughly
16
heated immediately before service. The sous vide process is a
17
pasteurization step that reduces bacterial load but is not sufficient
18
to make the food shelf-stable. The process involves the following
19
steps:
20
(a)
21
partial cooking of some or all ingredients);
22
(b)
23
Packaging of the product, application of vacuum, and
sealing of the package;
24
(c)
25
Pasteurization of the product for a specified and
monitored time/temperature;
26
(d)
Rapid and monitored cooling of the product at or below
3oC (38oF) or frozen; and
27
28
(e)
29
30
Preparation of the raw materials (this step may include
Reheating of the packages to a specified temperature
before opening and service.
(5)
Vacuum Packaging reduces the amount of air from a package and
Guam Food Code Annex 4 – Food Processing Criteria
3
1
hermetically seals the package so that a near-perfect vacuum
2
remains inside. A common variation of the process is Vacuum Skin
3
Packaging (VSP). A highly flexible plastic barrier is used by this
4
technology that allows the package to mold itself to the contours of
5
the food being packaged.
6
(C)
Benefits of ROP
7
ROP can create a significantly anaerobic environment that prevents the growth of
8
aerobic spoilage organisms, which generally are Gram-negative bacteria such as
9
pseudomonads or aerobic yeast and molds. These organisms are responsible for
10
off-odors, slime, and texture changes, which are signs of spoilage.
11
ROP can be used to prevent degradation or oxidative processes in food products.
12
Reducing the oxygen in and around a food retards the amount of oxidative rancidity
13
in fats and oils. ROP also prevents color deterioration in raw meats caused by
14
oxygen. An additional effect of sealing food in ROP is the reduction of product
15
shrinkage by preventing water loss.
16
These benefits of ROP allow an extended shelf life for foods in the distribution
17
chain, providing additional time to reach new geographic markets or longer display
18
at retail. Providing an extended shelf life for ready-to-eat convenience foods and
19
advertising foods as “Fresh – Never Frozen” are examples of economic and
20
quality advantages.
21
(D)
22
Use of ROP with some foods can markedly increase safety concerns. Unless
23
potentially hazardous foods (time/temperature control for safety foods) are
24
protected inherently, simply placing them in ROP without regard to microbial
25
growth will increase the risk of
26
regulators must assume that during distribution of foods or while foods are held by
27
retailers or consumers, refrigerated temperatures may not be consistently
28
maintained. In fact, a serious concern is that the increased use of vacuum
29
packaging at retail supermarket deli-type operations may be followed by
30
temperature abuse in the establishment or by the consumer. Consequently, at
Safety Concerns
foodborne illnesses.
ROP processors and
Guam Food Code Annex 4 – Food Processing Criteria
4
1
least one barrier or multiple hurdles resulting in a barrier need to be incorporated
2
into the production process for products packaged using ROP. The incorporation of
3
several sub-inhibitory barriers, none of which could individually inhibit microbial
4
growth but which in combination provide a full barrier to growth, is necessary to
5
ensure food safety.
6
Some products in ROP contain no preservatives and frequently do not possess
7
any intrinsic inhibitory barriers (such as, pH, a w, or salt concentrations) that either
8
alone or in combination will inhibit microbial growth. Thus, product safety is not
9
provided by natural or formulated characteristics.
10
An anaerobic environment, usually created by ROP, provides the potential for
11
growth of several important pathogens. Some of these are psychotropic and grow
12
slowly at temperatures near the freezing point of foods. Additionally, the inhibition
13
of the spoilage bacteria is significant because without these competing organisms,
14
tell-tale signs signaling that the product is no longer fit for consumption will not
15
occur.
16
The use of one form of ROP, vacuum packaging, is not new. Many food products
17
have a long and safe history of being vacuum packaged in ROP. However, the
18
early use of vacuum packaging for smoked fish had disastrous results, causing a
19
long-standing moratorium on certain uses of this technology.
20
(1)
Refrigerated Holding Requirements for Foods in ROP
21
Safe use of ROP technology demands that adequate refrigeration be maintained
22
during the entire shelf-life of potentially hazardous foods (time/temperature control
23
for safety foods) to ensure product safety.
24
Bacteria, with the exception of those that can form spores, are eliminated by
25
pasteurization. However,
26
pasteurization is inadequate, poor quality raw materials or poor handling practices
27
are used, or post-processing contamination occurs. Even if foods that are in ROP
28
receive adequate thermal processing, a particular concern is present at retail when
29
employees open manufactured products and repackage them. This operation
30
presents the potential for post-processing contamination by pathogens.
pathogens may survive in the final product if
Guam Food Code Annex 4 – Food Processing Criteria
5
1
If products in ROP are subjected to mild temperature abuse, i.e., 5o-12oC (41o-53oF),
2
at any stage during storage or distribution, foodborne pathogens, including Bacillus
3
cereus,
4
parahaemolyticus, can grow slowly. Marginal refrigeration that does not facilitate
5
growth may still allow Salmonella spp., Campylobacter spp., and Brucella spp. to
6
survive for long periods of time.
7
Published surveys indicate that refrigeration practices at retail need improvement.
8
Some refrigerated products offered in convenience stores were found at or above
9
7.2oC (45oF) 50% of the time; in several cases temperatures as high as 10oC (50oF)
10
were observed. Delicatessen display cases have been shown to demonstrate poor
11
temperature control. Foods have been observed above 10 oC (50oF) and above
12
12.8oC (55oF) in several instances. Supermarket fresh meat cases appear to have
13
a relatively good record of temperature control. However, even these foods can
14
occasionally be found above 10oC (50oF).
15
Temperature abuse is common throughout distribution and retail markets. Strict
16
adherence to temperature control and shelf-life must be observed and documented
17
by the establishment using ROP. Information on temperature control should also be
18
provided to the consumer. Currently these controls are not extensively used.
19
Additionally, some commercial equipment is incapable of maintaining foods below
20
7.2oC (45oF) because of refrigeration capacity, insufficient refrigerating medium,
21
or poor maintenance.
22
Most warehouses and transport vehicles in U.S. distribution chains maintain
23
temperatures in the 0o-3.3oC (32o-38oF) range. It must be assumed, however, for
24
purposes of assessing risk, that occasionally temperatures of 10 oC (50oF) or higher
25
may occur for extended periods. At retail, further temperature abuse must also be
26
assumed. For instance, retail display cases can be as high as 13.3 oC (56oF) for
27
short periods and some refrigerated foods are provided no refrigeration for short
28
periods of time. These realities point to the need for establishments to implement
29
controls, such as buyer specifications, over refrigerated distribution systems so that
30
better temperature control can be ensured.
Salmonella
spp.,
Staphylococcus
aureus,
Guam Food Code Annex 4 – Food Processing Criteria
6
and
Vibrio
1
2
(2)
Control of Clostridium botulinum and Listeria monocytogenes in
Reduced Oxygen Packaged Foods
3
There has been an increased interest in vacuum packaging or MAP at retail using
4
conventional refrigeration for holding. Refrigerated foods packaged at retail may be
5
chilled either after they are physically prepared and repackaged, or packaged after
6
a cooking step. In either case but primarily the latter, germination of Clostridium
7
botulinum is the causative agent of botulism, a severe food poisoning
8
characterized by double vision, paralysis, and occasionally death.
9
safeguards must be employed to prevent reintroduction of pathogens. Chief among
Sanitary
10
these is Listeria monocytogenes.
11
Clostridium botulinum is the causative agent of
12
poisoning characterized by double vision, paralysis, and occasionally death. The
13
organism is an anaerobic spore-forming bacteria
14
neurotoxin. The spores are ubiquitous in nature, relatively heat-resistant, and can
15
survive most minimal heat treatments that destroy vegetative cells. Certain strains
16
of C. botulinum (type E and non-proteolytic types B and F), which have been
17
primarily associated with fish, are psychotropic and can grow and produce toxin at
18
temperatures as low as 3.3oC (38oF). Other strains of C. botulinum (type A and
19
proteolytic types B and F) can grow and produce toxin at temperatures slightly
20
above 10oC (50oF). If present, C. botulinum could potentially grow and render
21
toxigenic a food packaged and held in ROP because most other competing
22
organisms are inhibited by ROP. Therefore, the food could be toxic yet appear
23
organoleptically acceptable. This is particularly true of psychotropic strains of
24
C. botulinum that do not produce tell-tale proteolytic enzymes. Because botulism
25
is potentially deadly, foods held in anaerobic conditions merit regulatory concern
26
and vigilance.
27
The potential for botulism toxin to develop also exists when ROP is used after
28
heat treatments such as pasteurization, or sous vide, processing of foods which
29
will not destroy the spores of C. botulinum. Mild heat treatments in combination
30
with ROP may actually select for C. botulinum by killing off its competitors. If the
botulism,
that produces a
Guam Food Code Annex 4 – Food Processing Criteria
7
a severe food
potent
1
applied heat treatment does not produce commercial sterility, the food requires
2
refrigeration to prevent spoilage and ensure product safety. For this reason, sous
3
vide products are frequently flash frozen in liquid nitrogen and held in frozen
4
storage until use.
5
There is a further microbial concern with ROP at retail. Processed products such
6
as meats and cheeses which have undergone an adequate cooking step to kill
7
L. monocytogenes can be contaminated when opened, sliced, and repackaged at
8
retail.
9
opportunity for recontamination with pathogens if strict sanitary safeguards are
Thus, a simple packaging or repackaging operation can present an
10
not in place.
11
Processors of products using ROP should be cautious if they plan to rely on
12
refrigeration as the sole barrier that ensures product safety. This approach
13
requires very rigorous temperature
14
equipment. If extended shelf life is sought, a temperature of 3.3oC (38oF) or
15
lower must be maintained at all times to prevent outgrowth of C. botulinum and the
16
subsequent production of toxin. Listeria monocytogenes can grow at even lower
17
temperatures; consequently, appropriate use-by dates must be established and
18
readily apparent to the consumer. Since refrigeration alone does not guarantee
19
safety from pathogenic microorganisms, additional growth barriers must be
20
provided. Growth barriers are provided by hurdles such as low pH, aw, or short
21
shelf life, and constant monitoring of the temperature. Any one hurdle, or a
22
combination of several, may be used with refrigeration to control pathogenic
23
outgrowth.
24
(3)
controls and
monitored
refrigeration
Design of Heat Processes for Foods in Reduced Oxygen Packages
25
Heat processes for sous vide or cook-chill operations should be designed so that,
26
at a minimum, all vegetative pathogens are destroyed by a pasteurization process.
27
Special labeling of these products is necessary to ensure adequate warning to
28
consumers that these foods must be refrigerated at 5 C (41 F) and consumed by
29
the date required by the Code for that particular product.
30
The National Advisory Committee on Microbiological Criteria for Foods (NACMCF),
o
o
Guam Food Code Annex 4 – Food Processing Criteria
8
1
chartered by the U.S. Department of Agriculture (USDA) and the Department of
2
Health and Human Services (DHHS), commented on the microbial safety of
3
refrigerated foods containing cooked, uncured meat or poultry products that are
4
packaged for extended refrigerated shelf life and are ready-to-eat or prepared with
5
little or no additional heat treatment. The NACMCF recommended guidelines for
6
evaluating the ability of thermal processes to inactivate L. monocytogenes in
7
extended shelf life refrigerated foods. Specifically, it recommended a proposed
8
requirement for demonstrating that an ROP process provides a heat treatment
9
sufficient to achieve a 4 decimal log reduction (4D) of L. monocytogenes.
10
Other scientific reports recommend more extensive thermal processing. Thermal
11
processes for sous vide practiced in Europe are designed to achieve a 12-13 log
12
reduction (12-13D) of the target organism Streptococcus faecalis. It is reasoned
13
that thermal inactivation of this organism would ensure destruction of all other
14
vegetative pathogens.
15
Food manufacturers with adequate in-house research and development programs
16
may have the ability to design their own thermal processes. However, small
17
retailers and supermarkets may not be able to
18
challenge studies necessary to provide the same level of food safety. If a retail
19
establishment wishes to use an ROP process, microbiological studies should be
20
performed by, or in conjunction with, an appropriate process authority or person
21
knowledgeable in food microbiology who is acceptable to the regulatory authority.
22
Finally, if foods are held long enough, even under proper refrigeration, extended
23
shelf life may be a problem.
24
L. monocytogenes, conducted to determine the effect of CAP on shelf life, found
25
that CAP lengthened the time that all vegetables were considered acceptable, but
26
that populations of L. monocytogenes increased during that extended storage.
27
28
(4)
perform the microbiological
A study on fresh vegetables inoculated with
Consumer Handling Practices and In-Home Refrigerator
Temperatures
29
Extended shelf life provided by ROP is cause for concern because of the potential
30
for abuse by the consumer. Consumers often cannot, or do not, maintain adequate
Guam Food Code Annex 4 – Food Processing Criteria
9
1
refrigeration of potentially hazardous foods (time/temperature control for safety
2
foods) at home. Foods in ROP that are taken home might not be eaten until
3
enough time/temperature abuse has occurred to allow any pathogens present to
4
increase to levels which can increase the chance of illness. Under the best of
5
circumstances, home refrigerators can be expected to range between 5 o and 10oC
6
(41o-50oF). One study reported that home refrigerator temperatures in 21% of the
7
households surveyed were 10oC (50oF). Another study reported more than 1 of 4
8
home refrigerators are above 7.2 oC (45oF) and almost 1 of 10 are above 10 oC
9
(50oF). Thus, refrigeration alone cannot be relied on for ensuring microbiological
10
safety after foods in ROP leave the establishment.
11
Consumers have come to expect that certain packages of foods would be safe
12
without refrigeration. Low-acid canned foods have been thermally processed,
13
which
14
renders the food shelf-stable.
15
botulinum spores as well as all other foodborne pathogens. Yet consumers may
16
not understand that most products that are packaged in ROP are not commercially
17
sterile or shelf-stable and must be refrigerated. A clear label statement to keep
18
the product refrigerated must be provided to consumers.
19
The use of ROP has been extensively studied by regulators and the food industry
20
over the past several years. Recommendations have been adapted from the
21
Association of Food and Drug Officials “Retail Guidelines - Refrigerated Foods in
22
Reduced Oxygen Packages” and New York State Department of Agriculture and
23
Markets “Proposed Reduced Oxygen Packaging Regulations.” As provided in the
24
Food Code, some ROP operations may be conducted under provision 3-502.12
25
Reduced Oxygen Packaging, Criteria. Food that is packaged by an ROP method
26
under these provisions is considered safe while it is under the control of the
27
establishment and, if the labeling instructions are followed, while under the
28
control of the consumer.
29
(E)
30
The safety barriers for all processed foods held in ROP at retail must be verified in
Retort heating ensures the destruction of C.
Safety Barrier Verification
Guam Food Code Annex 4 – Food Processing Criteria
10
1
writing. This can be accomplished through written certification from the product
2
manufacturer. Independent laboratory analysis using methodology approved by
3
the regulatory authority can also be used to verify incoming product and should be
4
used to verify the barriers in a product that is packaged within the establishment
5
by an ROP method. It should be noted that the Association of Food and Drug
6
Officials (AFDO) guidelines recommend that laboratory analysis be conducted by
7
official methods of the AOAC International (AOAC).
8
The multiple barrier or hurdle efficacy should be validated by inoculated pack or
9
challenge studies. A product should be tested under abuse temperatures to
10
demonstrate product safety during the food's shelf life.
11
Any changes in product formulation or processing procedures are cause for
12
notification of the regulatory authority and a required approval of the revised ROP
13
process. A record of all safety barrier verifications should be updated every 12
14
months. This record must be available to the regulatory authority for review at the
15
time of inspection.
16
(F)
17
Meat and poultry products cured at a food processing plant regulated by the U.S.
18
Department of Agriculture using substances specified in 9 CFR 424, Preparation
19
and Processing Operations, are exempt from the safety barrier verification
20
requirements. Other ROP operations may be developed that do not meet the
21
provisions of Section 3-502.12 of the Code and that will require a variance and
22
prior approval by the regulatory authority under Section 3-502.11.
23
(G)
24
USDA Process Exemption
Recommendations for ROP Without Multiple Barriers
(1)
Employee Training
25
If ROP is used, employees assigned to packaging of the foods must have
26
documented proof that demonstrates familiarity with ROP guidelines in this Annex
27
and the potential hazards associated with these foods. At the discretion of the
28
regulatory authority, a description of the training and course content provided to
29
the employees must either be available for review or have prior approval by the
30
regulatory authority.
Guam Food Code Annex 4 – Food Processing Criteria
11
1
(2)
Refrigeration Requirements
2
Foods in ROP that have only one barrier, i.e., refrigeration, to C. botulinum, must
3
be refrigerated to 5oC (41oF) or below and marked with a use-by date within either
4
the manufacturer's labeled use-by date or 14 days after preparation at retail,
5
whichever comes first. Alternatively, foods packaged by ROP may be kept frozen if
6
freezing is used as the declared primary safety barrier. Any extension of shelf life
7
past 14 days will require a further variance that considers lower refrigeration
8
temperatures. Foods that are intended for refrigerated storage beyond 14 days
9
must be maintained at or below 3oC (38oF).
10
(3)
Labeling - Refrigeration Statements
11
All foods in ROP which rely on refrigeration as a barrier to microbial growth must
12
bear the statement “Important - Must be kept refrigerated at 5 oC (41oF)” or
13
“Important - Must be kept frozen,” in the case of foods which rely on freezing as a
14
primary safety barrier. The statement must appear on the principal display panel in
15
bold type on a contrasting background. Foods held under ROP which have lower
16
refrigeration requirements as a condition of safe shelf life must be monitored for
17
temperature history and must not be offered for retail sale if the temperature and
18
time specified in the variance are exceeded.
19
(4)
Labeling - “Use-by date”
20
Each container of food in ROP must bear a “use-by” date. This date cannot exceed
21
14 days from retail packaging or repackaging without a further variance granted by
22
the regulatory authority. The date assigned by a repacker cannot extend beyond
23
the manufacturer's recommended “pull date” for the food. The “use-by” date must
24
be listed on the principal display panel in bold type on a contrasting background.
25
Any label must contain a combination of a “sell-by” date and use-by instructions
26
which makes it clear that the product must be consumed within 14 days of retail
27
packaging or repackaging, as an acceptable alternative to a 14 day “use-by” date,
28
i.e., for product packaged on November 1, 1999 - “Sell by November 10, 1999” -
29
use within 4 days of sell-by date. Foods that are frozen before or immediately
30
after packaging and remain frozen until use should bear a “Keep frozen, use within
Guam Food Code Annex 4 – Food Processing Criteria
12
1
4 days after thawing” statement.
2
(H)
Foods Which Require a Variance Under Code Section 3-502.11 if
3
Packaged in Reduced Oxygen Atmosphere
4
(1)
Processed fish and smoked fish may not be packed by ROP unless
5
establishments are approved for the activity and inspected by the
6
regulatory authority. Establishments packaging such fish products,
7
and smoking and packing establishments, must be licensed in
8
accordance with applicable law.
9
premises by ROP if the establishment is approved by the regulatory
10
authority and has an approved scheduled process established by a
11
processing authority acceptable to the regulatory authority.
12
(2)
Caviar may be packed on the
Soft cheeses such as ricotta, cottage cheese, cheese spreads, and
13
combinations of cheese and other ingredients such as vegetables,
14
meat, or fish at retail must be approved for ROP and inspected by the
15
regulatory authority.
16
(3)
Meat or poultry products which are smoked or cured at retail, except
17
that raw food of animal origin which is cured in a USDA-regulated
18
processing plant, or establishment approved by the regulatory
19
authority to cure these foods may be smoked in accordance with
20
approved time/temperature requirements and packaged in ROP at
21
retail if approved by the regulatory authority.
22
(I)
23
All food establishments packaging food in a reduced oxygen atmosphere must
24
develop a HACCP plan and maintain the plan at the processing site for review by
25
the regulatory authority. For ROP operations the plan must include:
26
Hazard Analysis and Critical Control Point (HACCP) Operation
(1)
A complete description of the processing, packaging, and storage
27
procedures designated as critical control points, with attendant
28
critical
29
30
limits,
corrective
action
plans,
monitoring
and
verification schemes, and records required;
(2)
A list of equipment and food-contact packaging supplies used,
Guam Food Code Annex 4 – Food Processing Criteria
13
1
including compliance standards required by the regulatory authority,
2
i.e., USDA or a recognized third party equipment by
3
organization such as NSF International;
4
(3)
5
the evaluation
A description of the lot identification system acceptable to the
regulatory authority;
6
(4)
7
A description of the employee training program acceptable to the
regulatory authority;
8
(5)
A listing and proportion of food-grade gasses used; and
9
(6)
A standard operating procedure for method and frequency of cleaning
10
and sanitizing food-contact surfaces in the designated processing
11
area.
12
(J)
Precautions Against Contamination at Retail
13
Only unopened packages of food products obtained from sources that comply
14
with the applicable laws relating to food safety can be used to package at retail
15
in a reduced oxygen atmosphere. If it is necessary to stop packaging for a period
16
in excess of one-half hour, the remainder of that product must be diverted for
17
another use in the retail establishment.
18
(K)
19
Processed reduced oxygen foods that exceed the “use-by” date or manufacturer's
20
“pull date” cannot be sold in any form and must be disposed of in a proper manner.
21
(L)
22
All aspects of
23
specifically designated for this purpose. There shall be an effective separation to
24
prevent cross contamination between raw and cooked foods. Access to processing
25
equipment shall be restricted to responsible trained personnel who are familiar
26
with the potential hazards inherent in food packaged by an ROP method. Some
27
ROP procedures such as sous vide may require a “sanitary zone” or dedicated
28
room with restricted access to prevent contamination.
29
(M)
References
30
1.
Association of Food and Drug Officials, 1990. Retail Guidelines -
Disposition of Expired Product at Retail
Dedicated Area/Restricted Access
reduced
oxygen
packaging shall be conducted in an area
Guam Food Code Annex 4 – Food Processing Criteria
14
1
Refrigerated Foods in Reduced Oxygen Packages. J. Assoc. Food Drug
2
Office. 54(5):80-84.
3
2.
Berang, M.E., R.E. Brackett, and L.R. Beuchat., 1989. Growth of Listeria
4
monocytogenes on fresh vegetables stored under controlled atmosphere. J.
5
Food Prot. 52:702-705.
6
3.
Brown, W.L., 1991. Designing Listeria monocytogenes thermal inactivation
7
studies for extended-shelf-life refrigerated foods. Food Technol. 45(4):152-
8
153.
9
4.
Bryan, F.L., L.A. Seabolt, R.W. Peterson, and L.M. Roberts, 1978. Time-
10
temperature observations of food and equipment in airline catering
11
operations. J. Food Prot. 41: 80-92.
12
5.
Conner, D.E., V.N. Scott, D.T. Bernard, and D.A. Kautter, 1989. Potential
13
Clostridium botulinum hazards associated with
14
shelf-life refrigerated foods: a review. J. Food Safety 10:131-153.
15
6.
16
17
extended
Daniels, R.W., 1991. Applying HACCP to new-generation refrigerated foods
at retail and beyond. Food Technol. 45(4):122-124.
7.
Davidson, W.D., 1987. Retail store handling conditions for refrigerated
18
foods. Presented at a technical session “New extended shelf-life: low-acid
19
refrigerated foods” at the 80th annual convention of the National Food
20
Processors Association. Jan. 26, Chicago, IL.
21
8.
Doyle, M.P., 1991. Evaluating the potential risk from extended-shelf-life
22
refrigerated foods by Clostridium botulinum inoculation studies. Food
23
Technol. 44(4):154-156.
24
9.
Eklund, M.W., D.I. Wieler, and F. Polsky, 1967. Growth and toxin production
25
of nonproteolytic type B Clostridium botulinum at 3.3 to 5.6C. J. Bacteriol.
26
93:1461-1462.
27
10.
28
29
30
Harris, R.D., 1989. Kraft builds safety into next generation refrigerated
foods. Food Proc. 50(13):111-112,114.
11.
Hutton, M.T., P.A. Dhehak, and J.H. Hanlin, 1991. Inhibition of botulinum
toxin production by Pedicoccus acidilacti in temperature abused refrigerated
Guam Food Code Annex 4 – Food Processing Criteria
15
1
2
foods. J. Food Safety 11:255-267.
12.
3
4
Kalish, F., 1991. Extending the HACCP concept to product distribution.
Food Technol. 45(4):119-120.
13.
Knabel, S.J., H.W. Walker, P.A. Hartman, and A.F. Mendonca, 1990. Effects
5
of growth temperature and strictly anaerobic recovery on the survival of
6
Listeria monocytogenes during pasteurization. Appl. Environ. Microbiol.
7
56:370-376.
8
14.
9
10
Food Prot. 52:363-367.
15.
11
12
Moberg, L., 1989. Good manufacturing practices for refrigerated foods. J.
National Advisory Committee on Microbiological Criteria for Foods, 1991.
Listeria monocytogenes. Int. J. Food Microbiol. 14:185-246.
16.
National Advisory Committee on Microbiological Criteria for Foods, 1991. I
13
HACCP Principles, II Meat and Poultry, III Seafood. Food Control 2(4):202-
14
211.
15
17.
New York Department of Agriculture and Markets, 1993. Proposed Reduced
16
Oxygen Packaging Regulations. Division of Food Safety and Inspection, 1
17
Winners Circle, Albany, NY,12235, 6 pp.
18
18.
Nolan, D.A., D.C. Chamberlin and J.A. Troller, 1992. Minimal water activity
19
of Listeria monocytogenes and Listeria innocua. Int. J. Food Microbiol.
20
16:323-335.
21
19.
22
23
Palumbo, S. A., 1986. Is refrigeration enough to restrain foodborne
pathogens? J. Food Prot. 49:1003-1009.
20.
Refrigerated Foods and Microbiological Criteria Committee of the National
24
Food Processors Association, 1988. Safety considerations for new
25
generation refrigerated foods. Dairy Food Sanit. 8:5-7.
26
21.
27
28
Technol. 46(12):73-76.
22.
29
30
Rhodehamel, E.J., 1992. FDA concerns with sous vide processing. Food
Schimdt, C.F., R.V. Lechowich, and J.F. Folinazzo, 1961. Growth and toxin
production by type E C. botulinum below 40F. J. Food Sci. 26:626-630.
23.
Scott, V.N., 1989. Interaction of factors to control microbial spoilage of
Guam Food Code Annex 4 – Food Processing Criteria
16
1
2
refrigerated foods. J. Food Prot. 52:431-435.
24.
Smith, J.P., C. Toupin, B. Gagnon, R. Voyer, P.P. Fiset, and M.V. Simpson,
3
1990. Hazard analysis critical control point approach (HACCP) to ensure
4
the microbiological safety of sous vide processed meat/pasta product. Food
5
Microbiol. 7:177-198.
6
25.
7
8
Van Garde, S.J., and M. Woodburn, 1987. Food discard practices of
householders. J. Am. Diet. Assoc. 87:322-329.
26.
9
Wyatt, L.D., and V. Guy, 1980. Relationships of microbial quality of retail
meat samples and sanitary conditions. J. Food Prot. 43:385-389.
10
11
3.
SMOKING AND CURING
12
(A)
Introduction
13
Meat and poultry are cured by the addition of salt alone or in combination with one
14
or more ingredients such as sodium nitrite, sugar, curing accelerators, and
15
spices. These are used for partial preservation, flavoring, color enhancement,
16
tenderizing and improving yield of meat. The process may include dry curing,
17
immersion curing, direct addition, or injection of the curing ingredients. Curing
18
mixtures are typically composed of salt (sodium chloride), sodium nitrite, and
19
seasonings. The preparation of curing mixtures must be carefully controlled. A
20
number of proprietary mixtures which are uniform in composition are available. The
21
maximum residual sodium nitrite in the finished product is limited to 200 ppm by
22
the USDA Food Safety and Inspection Service (FSIS).
23
concentration of 120 ppm is usually sufficient for most purposes.
24
requirements for added nitrite may be found in USDA regulations, 9 CFR 424. It is
25
important to use curing methods which achieve uniform distribution of the curing
26
mixture in the meat or poultry product.
27
(B)
28
Cured meat and poultry can be divided into three basic categories: (1)
29
uncomminuted smoked products; (2) sausages; and (3) uncomminuted unsmoked
30
processed meats.
A sodium nitrite
Specific
Definitions
Guam Food Code Annex 4 – Food Processing Criteria
17
1
(1)
2
Uncomminuted smoked products - include bacon, beef jerky, hams,
pork shoulders, turkey breasts, turkey drumsticks.
3
(2)
Sausages - include both
4
products.
finely
ground
and
coarse
ground
5
Finely ground sausages include bologna, frankfurters, luncheon
6
meats and loaves, sandwich spreads, and viennas. Coarse ground
7
sausages include
8
summer sausages.
9
(3)
chorizos, kielbasa, pepperoni, salami, and
Cured sausages - may be categorized as: (1) raw, cured; (2)
10
cooked, smoked; (3) cooked, unsmoked; and (4) dry, semidry, or
11
fermented.
12
(4)
Uncomminuted, unsmoked processed products - include corned
13
beef, pastrami, pig's feet, corned tongues. This category of
14
products may be sold as either raw ready-to-cook or ready-to-
15
eat.
16
(C)
Incorporation of Cure Ingredients
17
Regardless of preparation
18
throughout the product.
19
products during mixing or comminuting. Proper and thorough mixing is necessary
20
whether the cure is added to the formulation in dry or solution form. Muscle
21
cuts may be cured by immersion into a curing (pickle) solution. These methods
22
depend on slow diffusion of the curing agents through the product. Products
23
must be properly refrigerated during immersion curing.
24
Several methods may be used to shorten curing times.
25
immersion curing greater than 49 oC (>120oF), injection by arterial pumping (e.g.,
26
hams), and stitch pumping by a series of hollow needles. If the injection method
27
is used, injection needles must be frequently monitored during processing to
28
ensure that they are not fouled or plugged.
29
Tumbling or massaging may also be used as an aid to hasten curing. Proper
30
sanitation must be observed to prevent contamination during this operation.
method,
cure
ingredients must be distributed
Cure ingredients may be
introduced into sausage
These include hot
Guam Food Code Annex 4 – Food Processing Criteria
18
1
The dry curing method, a similar process, may also be used. In this case, curing
2
ingredients are rubbed over cuts and surfaces of meat held under refrigeration.
3
Precautions must include wearing sanitary gloves when meat is handled. Product
4
temperature maintenance is critical.
5
(D)
6
Smoking is the process of exposing meat products to wood smoke. Depending
7
on the method, some products may be cooked and smoked simultaneously, smoked
8
and dried without cooking, or cooked without smoking. Smoke may be produced by
9
burning wood chips or using an approved liquid smoke preparation. Liquid smoke
10
preparations may also be substituted for smoke by addition directly onto the product
11
during formulation in lieu of using a smokehouse or another type of smoking
12
vessel. As with curing operations, a standard operating procedure must be
13
established to prevent contamination during the smoking process.
14
(E)
15
Meat may be fermented or dehydrated for preservation.
16
fermentation is to reduce the pH to below 4.6 and inhibit bacteria harmful to
17
health as well as bacteria which can cause spoilage.
18
be cured and then dehydrated to prevent germination and growth of bacterial
19
spores. Many fermented and dehydrated meats are made without a cooking
20
step.
21
important because Staphylococcus aureus can be introduced. Staphylococcus
22
aureus produces an enterotoxin that is heat stable
23
inactivated by subsequent cooking.
24
Processed pork products require treatment to destroy Trichinella spiralis. At
25
retail, products which contain raw pork and which are not subsequently cooked
26
must be produced from certified trichina-free pork or treated to destroy
27
trichinae.
28
requirements for destroying trichina in pork by heating, freezing, drying, or
29
smoking.
Smoking
Fermentation and Dehydration
Sanitary practices in the production of
USDA
The purpose of
Meat products may also
these products are extremely
and thus will not be
regulations, 9 CFR 318.10(c)(3),
establish
Guam Food Code Annex 4 – Food Processing Criteria
19
various
1
Some fermented and dry cured products are processed without cooking. The
2
labeling for these products should include instructions to the consumer to cook
3
thoroughly before consumption.
4
(F)
5
Recommendations for Safe Curing of Meat and Poultry
(1)
Posting of Acceptable Products
6
A list of products approved by the regulatory authority, or by an approved
7
knowledgeable authority on curing acceptable to the regulatory authority, must
8
be posted in the processing area of the establishment.
9
(2)
Employee Training
10
Employees assigned to cure meat or poultry must demonstrate familiarity with
11
these guidelines and the potential hazards associated with curing foods. A
12
description of the training and course content provided to the employees must
13
be available for review by the regulatory authority.
14
(3)
HACCP
15
A
HACCP plan is needed for all curing operations.
The
16
recommendations must be met to cure meat and poultry products in the
17
establishment. References are available from local USDA extension offices,
18
public libraries, and college or university food or meat science departments to
19
develop HACCP plans for curing meat and poultry.
20
(a)
21
The following are critical control points to be addressed:
following
Critical Control Points
22
(i)
Purchase of prepared cure mixes; or
23
(ii)
If cure mixes are blended on
the premises
instead of
24
acquired pre-mixed, mixing must be carefully controlled by
25
using calibrated weighing devices.
26
(iii)
Cure ingredients must be stored in a dry location. Cure must
27
be discarded if the package is wet or appears to have been
28
wetted.
29
(b)
Raw Material Handling
Guam Food Code Annex 4 – Food Processing Criteria
20
1
(i)
Thawing must be monitored and controlled to ensure
2
thoroughness
3
Improperly thawed meat could cause
4
penetration.
5
growth of pathogens.
6
(ii)
9
to
Temperature
prevent
temperature abuse.
insufficient
cure
abuse can cause spoilage or
Meat must be fresh. Curing may not be used to salvage
7
8
and
meat that has excessive bacterial growth or spoilage.
(c)
Formulating, Preparation and Curing
(i)
A formulation and preparation procedure must be
10
documented.
11
(ii)
All equipment and utensils must be cleaned and sanitized.
12
(iii)
Pieces must be prepared to uniform sizes to ensure uniform
13
cure penetration. This is extremely critical for dry and
14
immersion curing.
15
(iv)
Calibrated scales must be used to weigh ingredients.
16
(v)
A schedule or recipe must be established for determining
17
the exact amount of curing formulation to be used for a
18
specified weight of meat or meat mixture.
19
(vi)
Methods and procedures must be strictly controlled to ensure
20
21
uniform cure.
(vii)
Mixing of curing formulation with comminuted Ingredients
22
23
must be controlled and monitored.
(viii)
All surfaces of meat must be rotated and rubbed at intervals
24
of sufficient frequency to ensure cure penetration when a dry
25
curing method is used.
26
(ix)
27
28
Immersion curing requires periodic mixing of the batch to
facilitate uniform curing.
(x)
The application of salt during dry curing of muscle cuts
29
requires that the temperature of the product be strictly
30
controlled between 1.7°C (35oF) and 7.2°C (45oF). The lower
Guam Food Code Annex 4 – Food Processing Criteria
21
1
temperature is set to limit microbial growth and the upper
2
temperature is set for the purpose of ensuring cure
3
penetration.
4
318.10(c)(3)(iv) for specific details on dry curing.
5
(xi)
Refer
to
regulations
9 CFR
Curing solutions must be discarded daily unless they remain
6
with the same batch of
7
process.
8
USDA
(xii)
product during its entire curing
Injection needles must be inspected for plugging when stitch
9
pumping or artery pumping of muscle cuts is performed.
10
(xiii)
11
Sanitary casings must be provided for sausage, chub or loaf
forming.
12
(xiv)
13
Casings may not be stripped for reuse in forming additional
chubs or sausages from batch to batch.
14
(xv)
Hot curing of bacon bellies, hams, or any other products
15
must be performed at >49°C (120oF) as specified in 9 CFR
16
318.
17
18
(d)
Cooking and/or Smoking
(i)
When smokehouses are initially installed or structurally
19
modified, calibration of product heating characteristics must
20
be ascertained
21
should be run with full range of anticipated product loading.
22
Verification of
23
recorded in operational records of the smokehouse for these
24
various loads.
25
(ii)
by competent food technologists.
even
airflow
and
Tests
moisture should
be
Procedures for delivering the appropriate thermal treatment of
26
cooked meats in conformance with the Food Code must be
27
developed and used. (Also see 9 CFR 318.17 and 318.23 for
28
USDA requirements for meat products.)
29
73.9°C (165°F) should be used for cured poultry products.
30
(iii)
A minimum of
Cooking equipment that provides even temperature control
Guam Food Code Annex 4 – Food Processing Criteria
22
1
of the heating medium must be used.
2
(iv)
Products must be adequately separated to prevent overlap in
3
the cooking media whether immersed in hot water, sprayed
4
with hot water, steamed, or oven heated.
5
(v)
Calibrated temperature measuring devices must be used for
6
determining internal product temperatures.
7
(vi)
Temperature measuring device probes must be sanitized to
8
prevent contaminating products when internal temperatures
9
are measured.
10
(vii)
Calibrated temperature measuring devices must be used for
11
measuring temperatures of the heating medium.
12
(viii)
Raw products must be separated from cooked products.
13
(ix)
Time/temperature parameters of the cooking process must be
14
monitored and recorded. In some processes, the heating
15
medium temperature should also monitored.
16
17
(e)
Cooling
(i)
Cooling must be done in accordance with recommendations
18
in the Food Code or under a variance. The USDA Cooling
19
Guideline, FSIS Directive 7110.3 for special procedures for
20
cured products, provides specific guidance.
21
(ii)
Written cooling procedures must be established.
22
(iii)
Chill water used in water sprays or immersion chilling which
23
is in direct contact with products in casings or products
24
cooked in an impervious package must be properly
25
chlorinated.
26
(iv)
Chill water temperature must be monitored and controlled.
27
(v)
Chill water may not be reused until properly chlorinated.
28
29
30
Reclaimed chill water must be discarded daily.
(vi)
Product must be placed in a manner that allows chilled
water or air to uniformly contact the product for assurance
Guam Food Code Annex 4 – Food Processing Criteria
23
1
of uniform cooling.
2
(vii)
Internal temperatures must be monitored during cooling by
3
using calibrated temperature measuring devices.
4
(viii)
5
monitored.
6
(ix)
Temperatures of the cooling medium must be monitored and
7
recorded in accordance with a written procedure.
8
(x)
Handling of product must be
9
12
used in these procedures.
(f)
Fermentation and Drying
(i)
Temperature and time must be controlled and logs must be
13
14
maintained that record the
(ii)
Monitoring of the process must be recorded in a written log.
(iii)
Product must be kept separated to allow adequate air
17
18
monitoring of this process.
Humidity must be controlled by use of a humidistat.
15
16
minimized during cooling,
peeling of casing, and packaging. Sanitary gloves must be
10
11
Adequate cooling medium circulation must be maintained and
circulation during the process.
(iv)
Use of an active and pure culture must be ensured to effect
19
a rapid pH drop
20
produced culture is necessary and the culture must be used
21
according to the manufacturer's instructions.
22
(v)
(vi)
Handling of products must be minimized and only done with
sanitary gloves or sanitized utensils.
(vii)
Dry (unfermented) products may not be hot smoked until the
27
28
product. Use of commercially
of the fermentation cycle must be recorded.
25
26
the
Determination of the pH of fermented sausages at the end
23
24
of
curing and drying procedures are completed.
(viii)
Semi-dry
fermented
sausage
must
be
heated
sufficient
29
fermentation to a time/temperature
30
growth of pathogenic and spoilage organisms of concern.
Guam Food Code Annex 4 – Food Processing Criteria
24
to
after
control
1
(4)
Dedicated Area/Restricted Access
2
All aspects of curing operations must be conducted in an area specifically
3
designated for this purpose. There must be an effective separation to prevent
4
cross contamination between raw and cooked foods or cured and uncured foods.
5
Access to processing equipment
6
personnel who are familiar with the potential hazards inherent in curing foods.
7
(5)
shall be restricted to responsible trained
Equipment Cleaning and Sanitizing
8
The procedures for cleaning and sanitization must be accomplished according
9
to parts 4-6 and 4-7 of the Guam Food Code.
10
(G)
References
11
Judge, M., E. Aberle, J. Forrest, H. Hedrick, and R. Merkel, 1984. Principles of
12
Meat Science. Kendall/Hunt Publishing Company, Dubuque, IA.
13
Price, J. and B. Schweigert, 1978. The Science of Meat and Meat Products. Food
14
and Nutrition Press, Inc., Westport, CT.
15
16
17
18
19
Guam Food Code Annex 4 – Food Processing Criteria
25
Department of Public Health and Social Services
Division of Environmental Health
Food Establishment Inspection Report
REASON
GRADE
INSPECTION DATE
/
/
TIME IN
TIME OUT
Regular
Follow-up
09.27.10
Page
of
ESTABLISHMENT NAME
PERMIT HOLDER
RATING
Complaint
SANITARY PERMIT NO.
Investigation
LOCATION (Address)
Other:
ESTABLISHMENT TYPE
TELEPHONE
RISK CATEGORY
No. of Risk Factor/Intervention Violations
No. of Repeat Risk Factor/Invertention Violations
FOODBORNE ILLNESS RISK FACTORS AND PUBLIC HEALTH INTERVENTIONS
Circle designated compliance (IN, OUT, N/O, N/A) for each numbered item
IN = In compliance
OUT = Not in compliance
N/O = Not observed
Compliance Status
N/A = Not applicable
COS
R
PTS
Mark "X" in appropriate box for COS and/or R
COS = Corrected on site during inspection
R
PTS
Potentially Hazardous Food (TCS food)
Person in charge present, demonstrates
IN OUT
PTS = Demerit points
COS
Supervision
1
R = Repeat violation
Compliance Status
6
knowledge, and performance duties
Employee Health
16
IN OUT N/O N/A Proper cooking time and temperature
6
17
IN OUT N/O N/A Proper reheating procedures for hot holding
6
18
IN OUT N/O N/A Proper cooling time and temperature
6
2
IN OUT
Management awareness; policy present
6
19
IN OUT N/O N/A Proper hot holding temperatures
6
3
IN OUT
Proper use of reporting, restriction & exclusion.
6
20
IN OUT N/O N/A Proper cold holding temperatures.
6
21
IN OUT N/O N/A Proper date marking and disposition
6
22
IN OUT N/O N/A Time as a public health control: procedures & records
6
Good Hygiene Practices
4
IN OUT
N/O Proper eating, tasting, drinking, or tobacco use
6
5
IN OUT
N/O No discharge from eyes, nose, and mouth
6
6
IN OUT
N/O Hands clean and properly washed.
7
IN OUT N/A N/O
Preventing Contamination by Hands
8
IN OUT
6
No bare hand contact with ready-to-eat foods or
Adequate handwashing facilities supplied &
IN OUT N/O N/A
Consumer Advisory provided for raw or
undercooked foods
24
IN OUT N/O N/A
Pasteurized Foods used; prohibited foods not
offered
accessible
9
IN OUT
Food obtained from approved source.
6
IN OUT N/A N/O
Food received at proper temperature.
6
11
IN OUT
Food in good condition, safe, and unadulterated.
6
Required records available; shell stock tags,
Protection from Contamination
13
IN OUT N/A
Food seperated and protected.
6
14
IN OUT N/A
Food contact surfaces clean & sanitized.
6
15
IN OUT
Proper disposition of returned, previously served,
reconditioned, and unsafe food
6
6
Chemical
25
IN OUT N/O N/A Food additives: approved and properly used.
6
26
IN OUT N/O N/A Toxic substances properly identified, stored, used
6
26
IN OUT N/O N/A
Conformance with Approved Procedures
6
parasite destruction
6
Highly Susceptible Populations
6
10
IN OUT N/A N/O
23
6
approved alternate method properly followed
Approved Source
12
Consumer Advisory
Compliance with variance specialized process